Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBIO SB, INC.
United States·US-MF-000036462
Last updated September 17, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bio SB, Inc. manufacture?
Bio SB, Inc. specializes in in vitro diagnostic (IVD) products primarily used in immunohistochemistry (IHC) testing. Their portfolio includes chromogenic substrates like DAB (brown) and AEC (red) for enzyme-linked detection, antibody-based reagents for detecting specific analytes (such as cytokeratin and CD cell markers), and control slides for validation purposes. Examples include reagents for Helicobacter pylori, Candida albicans, and specialized tissue digestion solutions like the Mohs ImmunoDigestor. These products are designed for laboratory use in diagnostic workflows.
Where is Bio SB, Inc. based, and how does that affect its regulatory standing?
Bio SB, Inc. is based in the United States. Since it manufactures devices regulated by the FDA, its products must comply with U.S. regulatory requirements. The company’s devices fall under FDA’s Class I classification, which generally involves lower-risk devices requiring less stringent premarket review. However, compliance with FDA guidelines—such as listing in the UDI database—remains essential for market authorization.
Which regulatory registries or databases list Bio SB, Inc.’s devices?
Bio SB, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized way for the FDA to track and identify medical devices in the U.S. market. Listing in this database ensures traceability and compliance with FDA requirements for Class I devices, though it does not imply individual device approval—only that the manufacturer has registered their products as required.
How are Bio SB, Inc.’s devices classified by regulatory authorities?
Bio SB, Inc.’s devices are classified under the FDA’s Class I category. This classification is based on risk assessment: Class I devices are generally considered low-risk and pose minimal potential harm to users. As a result, they typically require less regulatory oversight than higher-risk classes (e.g., Class II or III), though they must still meet FDA compliance standards, such as proper labeling, manufacturing controls, and UDI registration. Classification does not guarantee market authorization—only that the device falls under a specific regulatory pathway.
What is the primary purpose of Bio SB, Inc.’s in vitro diagnostic (IVD) products?
Bio SB, Inc.’s IVD products are designed for laboratory use in immunohistochemistry (IHC) and related diagnostic testing. These include chromogenic substrates (e.g., DAB for brown staining), antibody reagents for detecting specific proteins (like cytokeratin or CD markers), and control slides to validate test accuracy. For example, their Helicobacter pylori control slides or BAP1 antibodies help pathologists confirm the presence of specific biomarkers in tissue samples. The products support accurate diagnostic workflows in clinical or research settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 5385 , Hollister Avenue, Santa Barbara, CA, United States
- Website
- biosb.com
- —
- —
- [email protected]
- Phone
- +1(800)561-1145
- PRRC Contact
- Jessica Dunston
- EUDAMED SRN
- US-MF-000036462
- FDA FEI Number
- 3008773547
- DUNS Number
- 102855447
Catalogue (5547)
Page 23 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hemoglobin A control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Lysozyme RPab | Concentrate, 1 ml | FDA UDI | Class I | Active |
| TintoFast Ki-67 RMab | Predilute, 7ml | FDA UDI | Class I | Active |
| Prostein/P501S Control Slides | BSB-9355-CS | FDA UDI | Class I | Active |
| Mouse/Rabbit PolyDetector AP, w/ALK Scarlet Detection System | Ready-to-use, 15 ml each | FDA UDI | Class I | Active |
| COX-2 RMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| Hepatitis B Virus Surface Antigen (A10F1) | BSB 5621 (ASR) | FDA UDI | Class I | Active |
| CD6 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto Desmoglein-3 MMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| Tinto NPM1/B23, MMab | Predilute, 7 ml | FDA UDI | Class I | Active |
| Mouse/Rabbit PolyDetector AP Label | Ready-to-use, 1000 ml each | FDA UDI | Class I | Active |
| Prolactin control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| TintoDeparaffinator Citrate 20X | 100 ml | FDA UDI | Class I | Active |
| SMAD4/DPC4 Control Slides | BSB-9378-CS | FDA UDI | Class I | Active |
| Tinto Adenovirus, MMab | Predilute, 15 ml | FDA UDI | Class I | Active |
| TFE3 Control Slides | BSB-9404-CS | FDA UDI | Class I | Active |
| Tinto Cytokeratin 5 & 6 (RM341) | BSB-3822-15 | FDA UDI | Class I | Active |
| Galectin-3 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Desmoglein-3 MMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| CD117 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| CD34 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Melanoma KBA.62 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Cytokeratin 5 & 6 & ERG control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Desmoglein-3 Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| p120 Catenin Control Slides | BSB-9319-CS | FDA UDI | Class I | Active |
| Tinto Cadherin-6, RMab | Predilute, 7 ml | FDA UDI | Class I | Active |
| PAX-8 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto Annexin A10 (RPab) | BSB-3834-15 | FDA UDI | Class I | Active |
| T-Bet/TBX-2 Control Slides | BSB-9395-CS | FDA UDI | Class I | Active |
| SOX10 RMab Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto HSP-27 RMab | Predilute, 7 ml | FDA UDI | Class I | Active |
| PSA RMab | Concentrate, 1 ml | FDA UDI | Class I | Active |
| PolyDetector HRP Yellow | BSB-0365-50 | FDA UDI | Class I | Active |
| SOX-11 Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Hematoxylin Counterstainer | 1000 ml | FDA UDI | Class I | Active |
| Egfr (31g7) | BSB 5473 (ASR) | FDA UDI | Class I | Active |
| Tinto Helicobacter Pylori (EP279) | BSB 3281 (ASR) | FDA UDI | Class I | Active |
| Adenovirus (20/11 and 2/6) | BSB 5040 (ASR) | FDA UDI | Class I | Active |
| Glucagon RPab | Concentrate, 1 ml | FDA UDI | Class I | Active |
| PAX-8 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Helicobacter pylori Cell Line Array (2-core: Positive and Negative)Control Slide | Control Slides, 5 | FDA UDI | Class I | Active |
| FluoroMounter | 200 ml | FDA UDI | Class I | Active |
| Tinto PMS2, MMab | Predilute, 15 ml | FDA UDI | Class I | Active |
| Kappa, RPab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| Cathepsin K Control Slides | BSB-9438-CS | FDA UDI | Class I | Active |
| GH Control Slides | BSB-9195-CS | FDA UDI | Class I | Active |
| Alpha-Fetoprotein RMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| Tinto NPM1/B23, MMab | Predilute, 15 ml | FDA UDI | Class I | Active |
| Tinto STAT6 (RM473) | BSB-3809-7 | FDA UDI | Class I | Active |
| Parafibromin Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.