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 8 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Annexin A1 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto CD5, RMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| Tinto Cytokeratin LMW AE1, MMab | Predilute, 15 ml | FDA UDI | Class I | Active |
| Tinto Herpes Simplex Virus II (BSB-116) | BSB 3463 (ASR) | FDA UDI | Class I | Active |
| IgD RPab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| Cytokeratin 10 RMab | Concentrate, 1 ml | FDA UDI | Class I | Active |
| TintoReagent Container 7mL | BSB-7454 | FDA UDI | Class I | Active |
| PolyDetector Liquid AEC HRP Red | Ready-To-Use 15 ml | FDA UDI | Class I | Active |
| GFAP RMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| Tinto Helicobacter pylori (Polyclonal) | BSB 5603 (ASR) | FDA UDI | Class I | Active |
| HER2 neu PolyDetector DAB HRP Brown Detection System | 150 tests | FDA UDI | Class I | Active |
| S-100 Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Mouse/Rabbit ImmunoDetector HRP Label | Ready-to-use, 50 ml | FDA UDI | Class I | Active |
| Tinto Herpes Simplex Virus II, RPab | Predilute, 3 ml | FDA UDI | Class I | Active |
| Cadherin17/LI-Cadherin control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Collagen Type IV Control Slides | BSB-9123-CS | FDA UDI | Class I | Active |
| Cytokeratin 7 RMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| Tinto CD19 RMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| Lambda Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Histone H3 Phospho Control Slides | BSB-9220-CS | FDA UDI | Class I | Active |
| Follicular Dendritic Cell MMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| CD117 c-Kit PolyDetector DAB HRP Brown | 150 tests | FDA UDI | Class I | Active |
| Claudin-4 Control Slides | BSB-9432-CS | FDA UDI | Class I | Active |
| Tinto MSH6 (RBT-MSH6) | BSB-3843-15 | FDA UDI | Class I | Active |
| Claudin 18.2 (RBT-CLDN18.2) | BSB-3835-05-ASR | FDA UDI | Class I | Active |
| OCT-4 control slide | Control Slides, 5 | FDA UDI | Class I | Active |
| Mouse/Rabbit ImmunoDetector AEC HRP Red Detection System | 5 ml each | FDA UDI | Class I | Active |
| Mouse Negative Control | 6 ml | FDA UDI | Class I | Active |
| Hydrophilic Plus Slides | BSB 7028 | FDA UDI | Class I | Active |
| CD163 RMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| Tinto EGFR (31G7) | BSB 5470 (ASR) | FDA UDI | Class I | Active |
| ImmunoDNA Background Blocker | 1000 ml | FDA UDI | Class I | Active |
| Mouse/Rabbit PolyDetector DAB HRP Brown Detection System | 100 ml each | FDA UDI | Class I | Active |
| CD5 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| PTEN MMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| Tinto Thyroglobulin, RMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| AldH1A1 RMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| 7-core HPV Cervical Cancer Cell Line Microarray Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Calretinin (RBT-CALB2) | BSB-3815-01 | FDA UDI | Class I | Active |
| Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet Detection System | 15 ml each (150 tests) | FDA UDI | Class I | Active |
| Mouse/Rabbit ImmunoDetector AP Label | Ready-to-use, 15 ml each | FDA UDI | Class I | Active |
| Mouse/Rabbit ImmunoDetector DAB HRP Brown | 100 ml each | FDA UDI | Class I | Active |
| C3c / FITC control slides | control slides, 5 | FDA UDI | Class I | Active |
| Rabbit FluoroDetector FITC with FluoroMounter with DAPI | 15 ml | FDA UDI | Class I | Active |
| Tinto PSA, RMab | Predilute, 7 ml | FDA UDI | Class I | Active |
| Tinto Bcl-x , RMab | Predilute, 15 ml | FDA UDI | Class I | Active |
| CMV Cell Line Array (2-core: Positive and Negative) Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto Desmoglein-3 MMab | Predilute, 7 ml | FDA UDI | Class I | Active |
| PMS2, MMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| Cytomegalovirus Control Slides | BSB-9160-CS | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.