Biochem Immunosystems (U.S.), Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Biochem Immunosystems (U.S.), Inc. makes
Biochem Immunosystems produces in-vitro diagnostic (IVD) immunoassay kits and automated laboratory analyzers, including the Biodata Testosterone MAIA Kit for hormone testing, the Biodata SR1 FAH-HCG enzyme immunoassay for pregnancy and fertility markers, and the Personallab Automated Microplate Analyzer for high-throughput sample processing. The company also manufactures hematology systems like the Spirit Hematology System (Models LE, CP, and AX) for blood cell analysis.
The company’s products are regulated under the U.S. Food and Drug Administration’s 510(k) pathway, with devices classified as Class I and Class II. These products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Biodata Testosterone Maia Kit Ref K955102
Regimes: 510(k) Registry: 510(k)Personallab Automated Microplate Analyzer Ref K971761
Regimes: 510(k) Registry: 510(k)Biodata SR1 Fah-Hcg Enzyme Immunoassay Kit Ref K954065
Regimes: 510(k) Registry: 510(k)Spirit Hematology System Model Le, Cp, & Ax Ref K960072
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biochem Immunosystems (U.S.), Inc. have in the registry?
The registry currently lists 4 devices for Biochem Immunosystems (U.S.), Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biochem Immunosystems (U.S.), Inc.'s devices?
Among its 4 most recently registered devices, Biochem Immunosystems (U.S.), Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Biochem Immunosystems (U.S.), Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Biochem Immunosystems (U.S.), Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biochem Immunosystems (U.S.), Inc. in the registry?
The most recently registered devices listed for Biochem Immunosystems (U.S.), Inc. include BIODATA TESTOSTERONE MAIA KIT, PERSONALLAB AUTOMATED MICROPLATE ANALYZER, BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT and SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX.