North American Biologicals, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What North American Biologicals, Inc. makes
North American Biologicals, Inc. manufactures blood group typing reagents, including substances A, B, and RH control products, as well as plasma pooling and heat-sealing equipment for laboratory use.
These devices are regulated under FDA’s 510(k) pathway, with most classified as Class I or Class II, and are listed in the FDA’s 510(k) database. The company operates within the United States.
Catalogue
Blood Group Substance A, B Ref K781896
Regimes: 510(k) Registry: 510(k)Blood Group Substance A Ref K781862
Regimes: 510(k) Registry: 510(k)Blood Group Substance B Ref K781895
Regimes: 510(k) Registry: 510(k)Plasmapooler Ref K801219
Regimes: 510(k) Registry: 510(k)Rh Control Ref K801425
Regimes: 510(k) Registry: 510(k)Plasma Pooler Heat Sealer Ref K820301
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does North American Biologicals, Inc. have in the registry?
The registry currently lists 6 devices for North American Biologicals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list North American Biologicals, Inc.'s devices?
Among its 6 most recently registered devices, North American Biologicals, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do North American Biologicals, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for North American Biologicals, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from North American Biologicals, Inc. in the registry?
The most recently registered devices listed for North American Biologicals, Inc. include BLOOD GROUP SUBSTANCE A, B, BLOOD GROUP SUBSTANCE A, BLOOD GROUP SUBSTANCE B and PLASMAPOOLER.