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Assure Labs Inc.
5250 Gulfton St #2C,
77081
Houston, TX
USA
USA
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Contact
Veronica Yu
Sales manager-America region
Andrea Xu
Sales manager -Latin America/South America/Central America
Maggie Liu
Sales manager-North American
Diego Yang
Sales manager-south america/mexico
Frank Luo
Sales manager-America
Email
frank@azure.bio
Our range of products
Product categories
- 03 Diagnostic tests
- 03.02 Immunochemistry testing, immunology testing
- 03.02.02 Diagnostic rapid tests
Diagnostic rapid tests
- POC AUTHORIZED! COVID-19 IgG/IgM Rapid Test Device
- COVID-19 Antigen Rapid Test Device
- COVID-19 Antigen ＆ Influzen A/B Combo Rapid Test Device
- COVID-19-FLUA-FLUB-RSV-ADV-Combo Test Device
- MDSAP! Influenza A/B Rapid Test Device
- MDSAP certificate! H. pylori Antibodies Rapid Test Device
- Handheld Drug of Abuse Reader
- FDA 510k! Turn-Key Split Cup MD-U621 Drugs of Abuse Integrated Cup
- FDA 510k! Dipstick Drug Screen Panels (Urine)
- Multi DOA Saliva Test Cup
- FDA 510k! Marijuana THC Rapid Test Device
- FDA 510k! Amphetamine9(AMP) Rapid Test 300 /500/ 1000ng/ml
- RSV Antigen Rapid Test Device (Nasal Secretions)
- Fluorescence Immunoassay Analyzer
- Pregnancy (HCG) Rapid Test
- Ovulation(LH)Rapid Test Device
- Blood Glucose Monitoring System
- Hemoglobin Monitoring System
- Cholesterol monitoring system
- ZIKA IgG/IgM Rapid Test Device
- MDSAP certificate! Malaria P.f/Pan Rapid Test Device
- Dengue IgG/IgM Rapid Test Device
Our products
Product category: Diagnostic rapid tests
POC AUTHORIZED! COVID-19 IgG/IgM Rapid Test Device
The COVID-19 IgG/IgM Rapid Test Kit is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma. The test is for professional use only.
Benefits:
Results in 15 minutes
High accurate
Easy to use
No equipment required
Features:
Packing Size:20 pcs/kit
Sample:Whole blood/Serum/Plasma
Sample Volume:5ul
Testing time:15min
Shelf life:24 mouths
Storeage condition:4-30℃
Packing Contents:
Tests
disposable pipettes
Buffer
Package insert
Performance:
For IgM detection
Relative sensitivity: 93.7% (86.0%-97.3%)*
Relative specificity: 99.1% (96.8%-99.8%)*
Overall agreement: 97.7% (95.4%-98.9%)*
*95% Confidence Interval
For IgG detection:
Relative sensitivity: 98.8% (93.5%-99.8%)*
Relative specificity: 98.7% (96.2%-99.5%)*
Overall agreement: 98.7% (96.7%-99.5%)*
*95% Confidence Interval
Benefits:
Results in 15 minutes
High accurate
Easy to use
No equipment required
Features:
Packing Size:20 pcs/kit
Sample:Whole blood/Serum/Plasma
Sample Volume:5ul
Testing time:15min
Shelf life:24 mouths
Storeage condition:4-30℃
Packing Contents:
Tests
disposable pipettes
Buffer
Package insert
Performance:
For IgM detection
Relative sensitivity: 93.7% (86.0%-97.3%)*
Relative specificity: 99.1% (96.8%-99.8%)*
Overall agreement: 97.7% (95.4%-98.9%)*
*95% Confidence Interval
For IgG detection:
Relative sensitivity: 98.8% (93.5%-99.8%)*
Relative specificity: 98.7% (96.2%-99.5%)*
Overall agreement: 98.7% (96.7%-99.5%)*
*95% Confidence Interval
Product category: Diagnostic rapid tests
COVID-19 Antigen Rapid Test Device
The COVID-19 Antigen Rapid Test Device is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasopharyngeal secretions and Oropharyngeal secretions. This test is intended for professional use only.
Benefits:
Directly detect SARS-CoV-2 virus
Easy to use
No equipment required
Rapid detection within 15 minutes
Features:
Packing Size:20 pcs/kit
Sample:Nasopharyngeal/Oropharyngeal Swab
Testing time:15min
Storeage condition:2-30℃
Performance:
Relative Sensitivity: 94.3 % (84.6% ~ 98.1%)*
Relative Specificity: 99.1 % (98.4% ~ 99.5%)*
Overall Agreement: 98.9 % (98.1% ~ 99.4%)*
*95% Confidence Interval
Benefits:
Directly detect SARS-CoV-2 virus
Easy to use
No equipment required
Rapid detection within 15 minutes
Features:
Packing Size:20 pcs/kit
Sample:Nasopharyngeal/Oropharyngeal Swab
Testing time:15min
Storeage condition:2-30℃
Performance:
Relative Sensitivity: 94.3 % (84.6% ~ 98.1%)*
Relative Specificity: 99.1 % (98.4% ~ 99.5%)*
Overall Agreement: 98.9 % (98.1% ~ 99.4%)*
*95% Confidence Interval
Product category: Diagnostic rapid tests
COVID-19 Antigen ＆ Influzen A/B Combo Rapid Test Device
The COVID-19 & Influenza A/B Antigen Combo Test Device is an in vitro immunoassay. The assay is for the direct and qualitative detection of Influenza A and B and SARS-CoV-2 viral nucleoprotein antigens from nasopharyngeal secretions. This test is intended for professional use only.
Benefits:
Detection and differentiation of flu, COVID-19 during respiratory season
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Nasopharyngeal Swab
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
For COVID-19 antigen :
Relative Sensitivity: 97.3 % (86.2%~99.5%) *
Relative Specificity: 100 % (89.0%~100%)*
Overall Agreement: 98.5 % (92.1%~99.7 %)*
*95% Confidence Interval
For Influenza A:
Positive agreement with Cell Culture: 83.3%(73.5%~90.0%) *
Negative agreement with Cell Culture: 92.0%(85.4%~95.7%) *
Total agreement with Cell Culture: 88.4%(83.1%~92.2%) *
*95% Confidence Interval
For Influenza B:
Positive agreement with Cell Culture: 82.4%(72.9%~89.0%) *
Negative agreement with Cell Culture: 94.3%(88.1%~97.4%) *
Total agreement with Cell Culture: 88.9%(83.7%~92.7%) *
*95% Confidence Interval
Benefits:
Detection and differentiation of flu, COVID-19 during respiratory season
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Nasopharyngeal Swab
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
For COVID-19 antigen :
Relative Sensitivity: 97.3 % (86.2%~99.5%) *
Relative Specificity: 100 % (89.0%~100%)*
Overall Agreement: 98.5 % (92.1%~99.7 %)*
*95% Confidence Interval
For Influenza A:
Positive agreement with Cell Culture: 83.3%(73.5%~90.0%) *
Negative agreement with Cell Culture: 92.0%(85.4%~95.7%) *
Total agreement with Cell Culture: 88.4%(83.1%~92.2%) *
*95% Confidence Interval
For Influenza B:
Positive agreement with Cell Culture: 82.4%(72.9%~89.0%) *
Negative agreement with Cell Culture: 94.3%(88.1%~97.4%) *
Total agreement with Cell Culture: 88.9%(83.7%~92.7%) *
*95% Confidence Interval
Product category: Diagnostic rapid tests
COVID-19-FLUA-FLUB-RSV-ADV-Combo Test Device
The FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device is an in vitro immunoassay. The assay is for the direct and qualitative detection of influenza A virus, influenza B virus, Respiratory Syncytial Virus (RSV), Adenovirus (ADV) and SARS-CoV-2 antigens from nasopharyngeal swab samples.
Benefits:
•Quick results in 15 minutes
•Detection and differentiation of flu, RSV, ADV and COVID-19 during respiratory season
•Identify the co-infections of flu,RSV,ADV and COVID-19
•Provide judgment on health care workers for the similar symptoms disease
Specification:
Specimen: Nasal Secretions
Storage:2-30℃，room temperature
Shelf life:24 mouths
Kit package:20pcs
Testing time:15 minutes
Benefits:
•Quick results in 15 minutes
•Detection and differentiation of flu, RSV, ADV and COVID-19 during respiratory season
•Identify the co-infections of flu,RSV,ADV and COVID-19
•Provide judgment on health care workers for the similar symptoms disease
Specification:
Specimen: Nasal Secretions
Storage:2-30℃，room temperature
Shelf life:24 mouths
Kit package:20pcs
Testing time:15 minutes
Product category: Diagnostic rapid tests
MDSAP! Influenza A/B Rapid Test Device
The Influenza A/B Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal/nasopharyngeal swabs and nasal washes/aspirates of humans. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. The test is not intended for the detection of influenza C viral antigens. Negative results do not preclude influenza A or B viral infections and should be confirmed via cell culture or molecular assay
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Nasal/NP Swab and Nasal Washes/Aspirate
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Nasal/NP Swab and Nasal Washes/Aspirate
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Product category: Diagnostic rapid tests
MDSAP certificate! H. pylori Antibodies Rapid Test Device
The H. pylori Antibody Rapid Test Device (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of specific IgG antibodies to Helicobacter pylori in human serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of H. pylori infection.
Benefits:
Results in 10 minutes
High accuracy
Easy to use
No equipment required
Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:10min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
Relative Sensitivity:>93.2% (89.5%-95.9%)*
Relative Specificity:>97.2% (94.9%-98.6%)*
Overall Agreement:>95.5% (93.5%-97.0%)*
*95% Confidence Interva
Benefits:
Results in 10 minutes
High accuracy
Easy to use
No equipment required
Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:10min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
Relative Sensitivity:>93.2% (89.5%-95.9%)*
Relative Specificity:>97.2% (94.9%-98.6%)*
Overall Agreement:>95.5% (93.5%-97.0%)*
*95% Confidence Interva
Product category: Diagnostic rapid tests
Handheld Drug of Abuse Reader
A maximum of 9 drugs can be tested at a time, with more than 40 tests covering all common drugs
Benefits:
Portable ＆rear camera
User-friendly interface
4.3’’ touch screen
Inner Thermal printer
Stores up to 5000 results
Precise & accurate results in 5-10 minutes
External power and built-in rechargeable battery
Data can be transferred via cloud，Wi-Fi，support GPS ,GLONASS ,Beidou ,Bluetooth, TF card
Application： Hospital, Laboratory, Medical center , On-site enforcement
Benefits:
Portable ＆rear camera
User-friendly interface
4.3’’ touch screen
Inner Thermal printer
Stores up to 5000 results
Precise & accurate results in 5-10 minutes
External power and built-in rechargeable battery
Data can be transferred via cloud，Wi-Fi，support GPS ,GLONASS ,Beidou ,Bluetooth, TF card
Application： Hospital, Laboratory, Medical center , On-site enforcement
Product category: Diagnostic rapid tests
FDA 510k! Turn-Key Split Cup MD-U621 Drugs of Abuse Integrated Cup
The Turn-Key Split Cup Drugs of Abuse Integrated Cup(Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of any combination of drugs of abuse in human urine specimens at the cut-off concentrations listed below:
ACE Acetaminophen 5000ng/mL
AMP d-Amphetamine 1000/500/300ng/mL
BAR Secobarbital 300ng/mL
BUP BUP-3-D-Glucuronide 10/5ng/mL
BZO Oxazepam 300/200/100ng/mL
COC Benzoylecgonine 300/150/100ng/mL
COT (-)-Cotinine 600/300/200ng/mL
EDDP 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine 300/100ng/mL
ETG Ethyl Glucuronide 500ng/mL
FYL Norfentanyl/Fentanyl 200/10ng/mL
HMO Hydromorphone 250ng/mL
K2 JWH-073/JWH-018 50ng/mL
KET Ketamine 1,000ng/mL
LSD 9,10-Didehydro-N,N-diethyl-6-methylergoline-8beta-carboxamide 50ng/mL
6-MAM 6-Monoacetylmorphine 10ng/mL
MDMA 3,4-Methylenediioxy-MET 1000/300ng/mL
MET Methamphetamine 1000/500/300ng/mL
MOP Morphine 300/200/100ng/mL
MPD Methylphenidate 300ng/mL
MQL Methaqualone 300ng/mL
MTD Methadone 300ng/mL
OPI Morphine 2000/1000ng/mL
OXY Oxycodone 300/100ng/mL
PCP Phencyclidine 25ng/mL
PPX D-Propoxyphene 300ng/mL
TCA Nortriptyline 1000ng/mL
THC 11-nor-△9-THC-9-COOH 200/150/50/25
TRA Tramadol 300/100ng/mL
ZOL Zolpidem 50ng/mL
ALC Alcohol 0.02%
Adulteration
（ StripA） Oxidants/ Specific Gravity / pH
Adulteration
（ StripB） Nitrite / Glutaraldehyde/Creatinine
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
ACE Acetaminophen 5000ng/mL
AMP d-Amphetamine 1000/500/300ng/mL
BAR Secobarbital 300ng/mL
BUP BUP-3-D-Glucuronide 10/5ng/mL
BZO Oxazepam 300/200/100ng/mL
COC Benzoylecgonine 300/150/100ng/mL
COT (-)-Cotinine 600/300/200ng/mL
EDDP 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine 300/100ng/mL
ETG Ethyl Glucuronide 500ng/mL
FYL Norfentanyl/Fentanyl 200/10ng/mL
HMO Hydromorphone 250ng/mL
K2 JWH-073/JWH-018 50ng/mL
KET Ketamine 1,000ng/mL
LSD 9,10-Didehydro-N,N-diethyl-6-methylergoline-8beta-carboxamide 50ng/mL
6-MAM 6-Monoacetylmorphine 10ng/mL
MDMA 3,4-Methylenediioxy-MET 1000/300ng/mL
MET Methamphetamine 1000/500/300ng/mL
MOP Morphine 300/200/100ng/mL
MPD Methylphenidate 300ng/mL
MQL Methaqualone 300ng/mL
MTD Methadone 300ng/mL
OPI Morphine 2000/1000ng/mL
OXY Oxycodone 300/100ng/mL
PCP Phencyclidine 25ng/mL
PPX D-Propoxyphene 300ng/mL
TCA Nortriptyline 1000ng/mL
THC 11-nor-△9-THC-9-COOH 200/150/50/25
TRA Tramadol 300/100ng/mL
ZOL Zolpidem 50ng/mL
ALC Alcohol 0.02%
Adulteration
（ StripA） Oxidants/ Specific Gravity / pH
Adulteration
（ StripB） Nitrite / Glutaraldehyde/Creatinine
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
Product category: Diagnostic rapid tests
FDA 510k! Dipstick Drug Screen Panels (Urine)
The DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to seven of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
AMP d-Amphetamine 1000 ng/ml
BAR Secobarbital 300 ng/ml
BZO Oxazepam 300 ng/ml
COC Benzoylecgonine 300 ng/ml
MOR Morphine 300 ng/ml
THC 11-nor-D9-THC-9-COOH 50 ng/ml
TML Tramadol 100 ng/ml
Benefits:
Results in 5 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
AMP d-Amphetamine 1000 ng/ml
BAR Secobarbital 300 ng/ml
BZO Oxazepam 300 ng/ml
COC Benzoylecgonine 300 ng/ml
MOR Morphine 300 ng/ml
THC 11-nor-D9-THC-9-COOH 50 ng/ml
TML Tramadol 100 ng/ml
Benefits:
Results in 5 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
Product category: Diagnostic rapid tests
Multi DOA Saliva Test Cup
The Rapid Response TMMulti DOA Saliva Test Cup is a rapid visual immunoassay for the qualitative detection of drugs of abuse in human oral fluid specimens. The test system consists of up to 16 membrane strips mounted in a plastic device. This test detects combinations of the following drugs at the concentrations listed below. Specific combinations will vary according to the test in question:
Amphetamine (AMP) 50ng/ml
Barbiturate(BAR) 50ng/ml
Benzodiazepine (BZO) 10ng/ml
Buprenorphine(BUP) 5ng/ml
Cocaine (COC) Cocaine 20ng/ml
Cotinine(COT) Cotinine 50ng/ml
EDDP(EDDP) 20ng/ml
K2 50ng/ml
Ketamine (KET) 50ng/ml
Methadone (MTD) 30ng/ml
Methamphetamine (MET) 50ng/ml
Ecstasy (MDMA) 50ng/ml
6-MAM 10ng/ml
Opiates (OPI) 40ng/ml
Opiates (OPI) 25ng/ml
Oxycodone(OXY) 20ng/ml
Phencyclidine (PCP) 10ng/ml
Propoxyphene(PPX) 50ng/ml
Marijuana (THC) 12ng/ml
Marijuana (THC parent) 40ng/ml
Alcohol（ALC） 0.02%
Benefits:
Results in 10 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:10min
Shelf life:24 mouths
Storeage condition:2-30℃
Amphetamine (AMP) 50ng/ml
Barbiturate(BAR) 50ng/ml
Benzodiazepine (BZO) 10ng/ml
Buprenorphine(BUP) 5ng/ml
Cocaine (COC) Cocaine 20ng/ml
Cotinine(COT) Cotinine 50ng/ml
EDDP(EDDP) 20ng/ml
K2 50ng/ml
Ketamine (KET) 50ng/ml
Methadone (MTD) 30ng/ml
Methamphetamine (MET) 50ng/ml
Ecstasy (MDMA) 50ng/ml
6-MAM 10ng/ml
Opiates (OPI) 40ng/ml
Opiates (OPI) 25ng/ml
Oxycodone(OXY) 20ng/ml
Phencyclidine (PCP) 10ng/ml
Propoxyphene(PPX) 50ng/ml
Marijuana (THC) 12ng/ml
Marijuana (THC parent) 40ng/ml
Alcohol（ALC） 0.02%
Benefits:
Results in 10 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:10min
Shelf life:24 mouths
Storeage condition:2-30℃
Product category: Diagnostic rapid tests
FDA 510k! Marijuana THC Rapid Test Device
The THC Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative presumptive detection of THC metabolites (11-nor-Δ9-THC-9-carboxylic acid) in human urine specimens.
Marijuana, cannabis or tetra-hydro-cannabinol (THC) is a hallucinogenic agent derived from the flowering portion of the hemp plant. Smoking is the primary method of use of marijuana/cannabis.Higher doses used by abusers produce central nervous system effects, altered mood and sensory
perceptions, loss of co-ordination, impaired short-term memory, anxiety, paranoia, depression,confusion,hallucinations and increased heart rate.
Benefits:
Results in 5 minutes
High accurate
Easy to use
Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
The results were >99.9% in agreement
Marijuana, cannabis or tetra-hydro-cannabinol (THC) is a hallucinogenic agent derived from the flowering portion of the hemp plant. Smoking is the primary method of use of marijuana/cannabis.Higher doses used by abusers produce central nervous system effects, altered mood and sensory
perceptions, loss of co-ordination, impaired short-term memory, anxiety, paranoia, depression,confusion,hallucinations and increased heart rate.
Benefits:
Results in 5 minutes
High accurate
Easy to use
Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
The results were >99.9% in agreement
Product category: Diagnostic rapid tests
FDA 510k! Amphetamine9(AMP) Rapid Test 300 /500/ 1000ng/ml
The AMP Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Amphetamine in human urine specimens
Amphetamine is a Schedule II controlled substance available by prescription (Dexedrine®) and is also available on the illicit market. Amphetamines are a class of potent sympathomimetic agents with therapeutic applications. They are chemically related to the human body’s natural catecholamines: epinephrine and norepinephrine. Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power.
Benefits:
Results in 5 minutes
High accurate
Easy to use
Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
Amphetamine is a Schedule II controlled substance available by prescription (Dexedrine®) and is also available on the illicit market. Amphetamines are a class of potent sympathomimetic agents with therapeutic applications. They are chemically related to the human body’s natural catecholamines: epinephrine and norepinephrine. Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power.
Benefits:
Results in 5 minutes
High accurate
Easy to use
Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
Product category: Diagnostic rapid tests
RSV Antigen Rapid Test Device (Nasal Secretions)
The RSV Antigen Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of respiratory syncytial virus (RSV) antigens from human nasal/nasopharyngeal swabs or nasal washes/aspirates. It is intended to aid in the rapid diagnosis of RSV infection. Negative results do not preclude RSV infection and should be confirmed via bacterial culture or molecular assay.
Benefits:
Results in 15 minutes
Over 98% Accuracy
Easy to use
Digital test
Features:
Packing Size:1pcs/kit
Sample:Nasal Secretions
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
PERFORMANCE：
Relative sensitivity: 97.9% (95.2%-99.1%)*
Relative specificity: 99.3% (98.1%-99.8%)*
Overall agreement: 98.8% (97.7%-99.4%)*
*95% Confidence Interval
Product category: Diagnostic rapid tests
Fluorescence Immunoassay Analyzer
The fluorescence immunoassay analyzer is compatible with a specific dry reagent based on fluorescence immune chromatography, which is used for immune fluorescence detection in human specimens. It can be applied to the central laboratory of medical institution, door/emergency laboratory, clinical department and other medical service points (such as community medical center), physical examination center, etc., also applicable to research laboratory.
Benefits:
Portable analyzer
Accurate results
Quantitative test
Features:
internal and external controls
Built-in thermal printer
More than 9900 results
LIS/HIS connection
USB port/ID card/ Ethernet
RS-232 port/LAN port/WIFI
333*251*157mm 2.5Kg
12V DV max 4A / 100-240V AC,50-60HZ
Test Items:
Cardiac Markers:TRO,DDM,CK-MB,NT-proBNP,MYO,cTnI,LP-PLA2
Inflammation Marks:CRP,SAA,PCT,IL-6,sST2,CRP＆SAA
Fertility Test:β-HCG,LH,FSH,Prog,PRL,E2,T
Tumor Marks:AFP,CEA,FRT,PSA,FOB
Renal Injury Markers:NGAL,Cys-C,β2-MG,MAU
Gastric function Marks:PGⅠ,PGⅡ
Thyroid Function:T3,TT4,TSH
Diabetic:HbA1c
others:Vd3,COR
Benefits:
Portable analyzer
Accurate results
Quantitative test
Features:
internal and external controls
Built-in thermal printer
More than 9900 results
LIS/HIS connection
USB port/ID card/ Ethernet
RS-232 port/LAN port/WIFI
333*251*157mm 2.5Kg
12V DV max 4A / 100-240V AC,50-60HZ
Test Items:
Cardiac Markers:TRO,DDM,CK-MB,NT-proBNP,MYO,cTnI,LP-PLA2
Inflammation Marks:CRP,SAA,PCT,IL-6,sST2,CRP＆SAA
Fertility Test:β-HCG,LH,FSH,Prog,PRL,E2,T
Tumor Marks:AFP,CEA,FRT,PSA,FOB
Renal Injury Markers:NGAL,Cys-C,β2-MG,MAU
Gastric function Marks:PGⅠ,PGⅡ
Thyroid Function:T3,TT4,TSH
Diabetic:HbA1c
others:Vd3,COR
Product category: Diagnostic rapid tests
Pregnancy (HCG) Rapid Test
The hCG Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine specimens. This kit is intended for using as an aid in the early detection of pregnancy.
Benefits:
Over 99% accuracy
Results in 3 minutes
Easy to use
No equipment required
Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:3min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
Relative Sensitivity:>99.9% (98.7%-99.9%)*
Relative Specificity:>99.9% (99.8%-100.0%)*
Overall Agreement:>99.9% (99.7%-99.9%)*
*95% Confidence Interval
Benefits:
Over 99% accuracy
Results in 3 minutes
Easy to use
No equipment required
Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:3min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
Relative Sensitivity:>99.9% (98.7%-99.9%)*
Relative Specificity:>99.9% (99.8%-100.0%)*
Overall Agreement:>99.9% (99.7%-99.9%)*
*95% Confidence Interval
Product category: Diagnostic rapid tests
Ovulation(LH)Rapid Test Device
The LH Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of luteinizing hormone in human urine specimens. This kit is intended for use as an aid in the detection of ovulation.
Benefits:
Results in 5 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
Benefits:
Results in 5 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃
Product category: Diagnostic rapid tests
Blood Glucose Monitoring System
Blood Glucose Monitoring System is designed to quantitatively measureglucose with fresh capillary whole blood or venous whole blood. The system is intended for use outside the human body as an aid to monitor the effectiveness of diabetes control. The Blood Glucose Monitoring System is not used for the diagnosis of the diabetes or test of newborns.
Benefits:
Low pain
Accurate result in just 5 seconds
Only a drop of blood required
Stores up to 200 results with date and time
Wide temperature humidity
Specifications
Feature Specification
Measurement range :20~600mg/dL(1.1-33.3mmol/L)
Sample:Fresh capillary or venous whole blood
Sample size:Approximate 1 microlitre
Measuring time:5 seconds
Meter size:84.7*52*18mm (L*W*H)
Battery life:6 months or approximately 1,000 tests
Benefits:
Low pain
Accurate result in just 5 seconds
Only a drop of blood required
Stores up to 200 results with date and time
Wide temperature humidity
Specifications
Feature Specification
Measurement range :20~600mg/dL(1.1-33.3mmol/L)
Sample:Fresh capillary or venous whole blood
Sample size:Approximate 1 microlitre
Measuring time:5 seconds
Meter size:84.7*52*18mm (L*W*H)
Battery life:6 months or approximately 1,000 tests
Product category: Diagnostic rapid tests
Hemoglobin Monitoring System
The Hemoglobin Meter is intended for the quantitative determination of Hemoglobin (Hb) and calculated Hematocrit (HCT) in capillary and venous human whole blood. The easy to operate system consists of a portable meter that analyzes the intensity and color of light reflected from the reagent area of a test strip, ensuring quick and accurate results.
Benefits
Testing time less than 15 seconds
Capillary and venous human whole blood
A single drop(10ul) of whole blood
High memory of 500 records
Specifications
Test Time:<15 seconds
Measurement Range:0-25.6 g/dL, 0-256 g/L or 0-15.9 mmol/L
Sample:Whole blood
Sample Volume:10 μL
Battery Life:100 hours or 1,000 tests
Memory:1,000 records
Meter Size:142 mm × 70 mm × 27 mm
Benefits
Testing time less than 15 seconds
Capillary and venous human whole blood
A single drop(10ul) of whole blood
High memory of 500 records
Specifications
Test Time:<15 seconds
Measurement Range:0-25.6 g/dL, 0-256 g/L or 0-15.9 mmol/L
Sample:Whole blood
Sample Volume:10 μL
Battery Life:100 hours or 1,000 tests
Memory:1,000 records
Meter Size:142 mm × 70 mm × 27 mm
Product category: Diagnostic rapid tests
Cholesterol monitoring system
The Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol (TC), High Density Lipoprotein Cholesterol(HDL), Triglycerides (TG), and the calculated ratio of TC/HDL and Low Density Lipoprotein Cholesterol (LDL) in human capillary blood. The easy to operate system consists of a portable meter that analyzes the intensity and color of light reflected from the reagent area of a test device, ensuring quick and accurate results.
Benefits:
Easy to use
Getting result in just 120 seconds
Large memory
Stores up to 500 results
Rapid detection
One test can get five results
Power saving mode
Benefits:
Easy to use
Getting result in just 120 seconds
Large memory
Stores up to 500 results
Rapid detection
One test can get five results
Power saving mode
Product category: Diagnostic rapid tests
ZIKA IgG/IgM Rapid Test Device
The ZIKA IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is an in vitro immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Zika virus in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of Zika infections. The results obtained should be confirmed with alternative testing method(s).
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Whole Blood/Serum/Plasma
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
The overall agreement for IgG test is 90%; the overall agreement for IgM test is 90%.
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Whole Blood/Serum/Plasma
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
The overall agreement for IgG test is 90%; the overall agreement for IgM test is 90%.
Product category: Diagnostic rapid tests
MDSAP certificate! Malaria P.f/Pan Rapid Test Device
The Malaria P.f/Pan Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Whole Blood
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
Relative Specificity: 99.1% (324/327)(97.3%～99.8%)*
Accuracy: 99.4% (535/538)(98.3%～99.8%)*
For Pan:
Relative Sensitivity: >99.9% (158/158) (97.6%～100.0%)*
For P.f:
Relative Sensitivity: >99.9% (53/53) (93%～100.0%)*
*95% Confidence Interval
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Whole Blood
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
Relative Specificity: 99.1% (324/327)(97.3%～99.8%)*
Accuracy: 99.4% (535/538)(98.3%～99.8%)*
For Pan:
Relative Sensitivity: >99.9% (158/158) (97.6%～100.0%)*
For P.f:
Relative Sensitivity: >99.9% (53/53) (93%～100.0%)*
*95% Confidence Interval
Product category: Diagnostic rapid tests
Dengue IgG/IgM Rapid Test Device
The Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Denguevirus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Whole Blood/Serum/Plasma
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
For Dengue IgM test：
Relative sensitivity:98.3%(91.1%～99.7%)*
Relativespecificity: >99.9%(97.3%～100.0%)*
Overall agreement: 99.5%(97.2%～99.9%)*
*95% Confidence Interval
For Dengue IgG test:
Relative sensitivity:
98.9%(94.0%～99.8%)*
Relative specificity:
>99.9%(97.5%～100.0%)*
Overall agreement:
99.6%(97.7%～99.9%)*
*95% Confidence Interval
Benefits:
Results in 15 minutes
High accurate
Easy to use
Features:
Packing Size:25 pcs/kit
Sample:Whole Blood/Serum/Plasma
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃
Performance:
For Dengue IgM test：
Relative sensitivity:98.3%(91.1%～99.7%)*
Relativespecificity: >99.9%(97.3%～100.0%)*
Overall agreement: 99.5%(97.2%～99.9%)*
*95% Confidence Interval
For Dengue IgG test:
Relative sensitivity:
98.9%(94.0%～99.8%)*
Relative specificity:
>99.9%(97.5%～100.0%)*
Overall agreement:
99.6%(97.7%～99.9%)*
*95% Confidence Interval
About us
Company details
Azure Biotech, Inc.is a high-tech biotechnology company that specializes in research & development, production and sales of diagnostic reagents, POCT analyzers, and biological materials. We utilize advanced colloidal gold diagnostic reagents production lines to produce hundreds of millions of devices each year. Currently, our R&D team has over 100 employees, along with extensive collaborations with renowned domestic and foreign research institutions.