Azure Biotech Inc. of Houston, TX at MEDICA 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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Azure Biotech Inc.

P.O. Box NA, 77081 Houston, TX
5250, Gulfton St. Ste 2c, 77081 Houston, TX
USA
Telephone +1 713 5615529
info@azure.bio

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This company is co-exhibitor of
Messe Düsseldorf North America

Hall map

MEDICA 2021 hall map (Hall 3): stand D45-1

Fairground map

MEDICA 2021 fairground map: Hall 3

Our range of products

Product categories

  • 03  Diagnostic tests
  • 03.02  Immunochemistry testing, immunology testing
  • 03.02.02  Diagnostic rapid tests

Our products

Product category: Diagnostic rapid tests

Assure COVID-19 IgG/IgM Rapid Test Device

The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Assure COVID-19 IgG/IgM Rapid Test Device should not be used to diagnose acute SARS-CoV-2 infection. 

Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.


Warning
This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.

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Product category: Diagnostic rapid tests

Digital Pregnancy Test

- Over 99% accuracy at detecting the pregnancy hormone.
- It takes 3 minutes for the results.
- Yes/No Readout

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Product category: Diagnostic rapid tests

Hemoglobin Meter

Quantitative determination of hemoglobin and calculated hematocrit in capillary and venous human whole blood.

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About us

Company portrait

Azure Biotech Inc is a global biotechnology company that specializes in research & development, as well as the production and sales of diagnostic reagents, POCT analyzers and biological materials.

Azure Biotech is also heavily involved in research in the following fields: advanced rapid diagnostic reagents, rapid molecular diagnostic platforms, the development and preparation of antibodies for several illnesses, small molecular antigen synthesis, and genetic engineering. Also, Azure Biotech is committed to the research and production of in vitro diagnostic reagents and related POCT analyzer products (such as colloidal gold rapid detection reagents), quantitative determination of chemiluminescent immunoassay reagents, and bioactive materials. More than 100 products in 9 series have been successfully developed and are currently marketed, including but not limited to: pregnancy test, DOA tests, infectious disease tests, tumor marker tests, cardiac marker tests, food safety tests, biochemical reagent series, allergy tests, integrated instruments, and reagents.

Azure Biotech products are sold to more than 100 countries and regions in Europe, Asia, Africa, Oceania, and America. In particular, our drug detection reagents have won wide praise, dominating more than 60% of market share in some European countries.

 
Mission
Our mission is to provide excellent IVD health care products that satisfy the needs of our customers, and help contribute to the health of humanity as a whole.

Azure Bio does this by utilizing cutting-edge science, innovative thinking and reliable technology. Our labs employ efficient but continuously monitored and improved quality control systems, ensuring that everything we produce will help us achieve our mission. Azure has a vision to be the leading provider of IVD products, and in many cases around the globe, we have met and continue to maintain that vision.