Biosafe Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Biosafe Laboratories, Inc. makes
Biosafe Laboratories, Inc. manufactures at-home blood collection and transport systems for diagnostic testing, including devices for hemoglobin A1c monitoring, cholesterol profile analysis, and thyroid stimulating hormone (TSH) testing. Their portfolio also includes a self-screening device for anemia detection and specialized capillary blood transport systems for laboratory use.
The company’s products are regulated under FDA Class I and Class II classifications, with several devices cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Anemiapro Self-Screener Ref K042379
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biosafe Laboratories, Inc. have in the registry?
The registry currently lists 6 devices for Biosafe Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosafe Laboratories, Inc.'s devices?
Among its 6 most recently registered devices, Biosafe Laboratories, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Biosafe Laboratories, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Biosafe Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosafe Laboratories, Inc. in the registry?
The most recently registered devices listed for Biosafe Laboratories, Inc. include ANEMIAPRO SELF-SCREENER, SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC, SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM and BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM.