Azure Medical, Inc.
Developer, manufacturer and distributor of in vitro diagnostic (IVD) products and point-of-care analyzers. Activities include research and development of rapid diagnostic reagents and molecular platforms, production and global sales of a range of rapid tests and analyzers, and preparation of regulatory documentation for emergency authorizations for COVID-19 tests.
Industries
N/A
Products
Rapid antigen home test (OTC) for SARS-CoV-2
Lateral-flow antigen test designed for non-prescription home use with anterior nasal swab specimens and serial-testing recommendations; associated EUA documentation and IFUs are provided.
Point-of-care/clinic antigen pen test
Antigen test formatted for pen-style specimen collection and home or point-of-care use, with EUA-authorized labeling and healthcare professional IFUs.
Serology IgG/IgM rapid test (lateral flow)
Rapid lateral-flow immunoassay for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in venous and capillary whole blood, serum or plasma; includes POC and laboratory use instructions and EUA materials.
Rapid test reader systems (portable optical readers)
Portable optical/photoelectric readers for quantitative or qualitative interpretation of colloidal-gold and other rapid test strips, with mobile app support, result storage and interfaces for data export and LIS connectivity.
Portfolio of rapid diagnostic tests (multiple indications)
Range of rapid tests and reagents across indications including pregnancy, drug-of-abuse, infectious disease, tumor markers, cardiac markers, fertility, food safety and biochemical assays.
Rapid antigen home test (OTC) for SARS-CoV-2
Lateral-flow antigen test designed for non-prescription home use with anterior nasal swab specimens and serial-testing recommendations; associated EUA documentation and IFUs are provided.
Point-of-care/clinic antigen pen test
Antigen test formatted for pen-style specimen collection and home or point-of-care use, with EUA-authorized labeling and healthcare professional IFUs.
Serology IgG/IgM rapid test (lateral flow)
Rapid lateral-flow immunoassay for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in venous and capillary whole blood, serum or plasma; includes POC and laboratory use instructions and EUA materials.
Rapid test reader systems (portable optical readers)
Portable optical/photoelectric readers for quantitative or qualitative interpretation of colloidal-gold and other rapid test strips, with mobile app support, result storage and interfaces for data export and LIS connectivity.
Portfolio of rapid diagnostic tests (multiple indications)
Range of rapid tests and reagents across indications including pregnancy, drug-of-abuse, infectious disease, tumor markers, cardiac markers, fertility, food safety and biochemical assays.
Expertise Areas
- In vitro diagnostic (IVD) development
- Point-of-care and home diagnostic testing
- Lateral-flow immunoassays and colloidal-gold assays
- Assay chemistry and reagent formulation
Key Technologies
- Lateral-flow immunoassay (LFIA)
- Colloidal-gold labeling
- Chemiluminescent immunoassay
- Point-of-care analyzers