American Bio-Science Laboratories
Country not established
- Devices
- 2
What American Bio-Science Laboratories makes
American Bio-Science Laboratories manufactures reagent kits for laboratory testing, including cortisol and thyroid hormone (T3) assays. These products are designed for use in clinical diagnostics to measure hormone levels in patient samples.
The company’s portfolio is regulated as Class II medical devices in the US, with relevant products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Amer. Bio-Science Lab Cortisol Reagent Ref K842455
Regimes: 510(k) Registry: 510(k)Amer. Bio-Science Lab T3 Reagents Ref K842590
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Bio-Science Laboratories have in the registry?
The registry currently lists 2 devices for American Bio-Science Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Bio-Science Laboratories's devices?
Among its 2 most recently registered devices, American Bio-Science Laboratories has devices listed in FDA 510(k) (2 devices).
What risk classes do American Bio-Science Laboratories's devices fall under?
Among its 2 most recently registered devices, the classes recorded for American Bio-Science Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Bio-Science Laboratories in the registry?
The most recently registered devices listed for American Bio-Science Laboratories include AMER. BIO-SCIENCE LAB CORTISOL REAGENT and AMER. BIO-SCIENCE LAB T3 REAGENTS.