Northeast Biomedical Labs., Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Northeast Biomedical Labs., Inc. makes
Northeast Biomedical Labs., Inc. produces biological products for diagnostic and therapeutic use, including guinea pig whole serum and goat-derived antisera targeting rubella and influenza viruses. These antisera are designed for serological testing and immune response assessment in clinical and research settings.
The company’s portfolio includes Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These products are listed under U.S. regulatory frameworks and are manufactured in the United States.
Catalogue
Guinea Pig Whole Serum Ref K780009
Regimes: 510(k) Registry: 510(k)Goat Anti-Rubella Antisera Ref K780010
Regimes: 510(k) Registry: 510(k)Goat Anti-Influenza Antisera Ref K780008
Regimes: 510(k) Registry: 510(k)Goat Anti-Influenza Antisera Ref K780005
Regimes: 510(k) Registry: 510(k)Goat Anti-Influenza Antisera Atexas Ref K780697
Regimes: 510(k) Registry: 510(k)Goat Anti-Influenza Antisera Ref K780007
Regimes: 510(k) Registry: 510(k)Goat Anti-Influenza Antisera Ref K780004
Regimes: 510(k) Registry: 510(k)Goat Anti-Influenza Antisera Ref K780006
Regimes: 510(k) Registry: 510(k)Goat Antiinfluenza Antisera Aussr Ref K780696
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Northeast Biomedical Labs., Inc. have in the registry?
The registry currently lists 9 devices for Northeast Biomedical Labs., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Northeast Biomedical Labs., Inc.'s devices?
Among its 9 most recently registered devices, Northeast Biomedical Labs., Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Northeast Biomedical Labs., Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Northeast Biomedical Labs., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Northeast Biomedical Labs., Inc. in the registry?
The most recently registered devices listed for Northeast Biomedical Labs., Inc. include GUINEA PIG WHOLE SERUM, GOAT ANTI-RUBELLA ANTISERA, GOAT ANTI-INFLUENZA ANTISERA and GOAT ANTI-INFLUENZA ANTISERA ATEXAS.