Bio Sb, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000036462 FEI 3008773547
- Devices
- 5,558
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- QAdvis EAR ABSE
What Bio Sb, Inc. makes
Bio SB, Inc. manufactures in vitro diagnostic (IVD) products for immunohistochemistry, including chromogenic substrates, enzyme-linked detection kits, and antibody-based reagents. Their portfolio includes enzyme immunohistochemistry substrates like DAB and AEC, as well as specific detection antibodies such as cytokeratin and CD cell markers. Control slides and reagents for analytes like Helicobacter pylori, Candida albicans, and BAP1 are also produced, alongside specialized digestion solutions for tissue processing.
The company’s products are classified under FDA’s Class I medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for laboratory use in diagnostic testing and are regulated under U.S. FDA guidelines. The manufacturer operates within the United States.
Catalogue
Search and filter all 5,558 devicesShowing 1-50 of 5,558
Company details
- EUDAMED SRN
- US-MF-000036462
- FDA FEI number
- 3008773547
- DUNS number
- 102855447
- EUDAMED status
- Active
- EUDAMED registered name
- Bio SB Inc
- EUDAMED abbreviated name
- Bio SB
- Registered address
- 5385, Hollister Avenue, 93111, Santa Barbara, CA, United States
- Website
- biosb.com
- ra@biosb.com
- Phone
- +1(800)561-1145
- PRRC contact
- Jessica Dunston
Frequently asked questions
How many devices does BIO SB, INC. have in the registry?
The registry currently lists 5558 devices for BIO SB, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIO SB, INC.'s devices?
Among its 50 most recently registered devices, BIO SB, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do BIO SB, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for BIO SB, INC.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from BIO SB, INC. in the registry?
The most recently registered devices listed for BIO SB, INC. include Mouse/Rabbit ImmunoDetector DAB HRP Brown 1000 ml each, Mouse/Rabbit ImmunoDetector AEC HRP Red 50 ml each, BAP1 (RBT-BAP1) BSB-3839-01 and Mohs ImmunoDigestor Ancillary, 15ml.