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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 3 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Annexin A10 (RPab) | BSB-3834-05 | FDA UDI | Class I | Active |
| TintoFast CK CAM5.2 MMab | Predilute, 7ml | FDA UDI | Class I | Active |
| Cytokeratin 5 & 6 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| CA-125 RMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| CD25 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| FOXO1 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto CD5 RMab | Predilute, 15 ml | FDA UDI | Class I | Active |
| CD105/Endoglin RPab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| NPM1/B23, MMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| Fibrinogen Control Slides | BSB-9179-CS | FDA UDI | Class I | Active |
| CD45RO Control Slides | BSB-9098-CS | FDA UDI | Class I | Active |
| Beta-Catenin control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Cytokeratin 8 Control Slides | BSB-9151-CS | FDA UDI | Class I | Active |
| Tinto Cytokeratin 5 & ERG, RMab | Predilute, 7 ml | FDA UDI | Class I | Active |
| HER2 neu (EP3) | BSB 2513 (ASR) | FDA UDI | Class I | Active |
| Cyclin D1 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| 3-core Lung Cancer Cell Line Microarray Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| PNI Carcinoma MultiDetector Detection Systems kits | Ready-to-use, 150 tests each | FDA UDI | Class I | Active |
| CD146/MUC18/Mel-CAM control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Alpha-Fetoprotein Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Langerin / CD207 RMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| Mouse/Rabbit PolyDetector AEC HRP Red Detection System | 5 ml each | FDA UDI | Class I | Active |
| Pneumocystis jirovecii (3F6) | BSB 5880 (ASR) | FDA UDI | Class I | Active |
| Tinto AldH1A1, RMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| Tinto Parvovirus (R92F6) | BSB 5856 (ASR) | FDA UDI | Class I | Active |
| PSAP Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Mouse/Rabbit PolyDetector AP, w/ALK Scarlet Detection System | Ready-to-use, 200 ml each | FDA UDI | Class I | Active |
| PolyDetector Alk Magenta | 50 ml | FDA UDI | Class I | Active |
| Cytomegalovirus (8B1.2, 1G5.2 & 2D4.2) | BSB 5454 (ASR) | FDA UDI | Class I | Active |
| MDM2 Control Slides | BSB-9271-CS | FDA UDI | Class I | Active |
| Egfr (31g7) | BSB 5475 (ASR) | FDA UDI | Class I | Active |
| PolyDetector Alk Brown Ready-To-Use | 200 ml, | FDA UDI | Class I | Active |
| Tinto NPM1/B23, MMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| PolyDetector Alk Blue Ready-To-Use | 15 ml | FDA UDI | Class I | Active |
| c-Met/HGFR control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto SATB2 (RBT-SATB2) | BSB-3848-7 | FDA UDI | Class I | Active |
| c-Myc MMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| Tinto TdT RPab | Predilute, 15 ml | FDA UDI | Class I | Active |
| Tinto B7H3/CD276 (RBT-B7H3) | BSB 2812 (ASR) | FDA UDI | Class I | Active |
| MGMT/AGAT Control Slides | BSB-9279-CS | FDA UDI | Class I | Active |
| Epstein Barr Virus LMP-1 (CS1-4) | BSB 5489 (ASR) | FDA UDI | Class I | Active |
| Tinto PAX-8 RMab | Predilute, 7 ml | FDA UDI | Class I | Active |
| Mohs Mouse/Rabbit PolyDetector Plus HRP Green | BSB-0356-5 | FDA UDI | Class I | Active |
| Cytokeratin 20 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Helicobacter Pylori (BSB-37) | BSB 2682 (ASR) | FDA UDI | Class I | Active |
| CD11b Control Slides | BSB-9062-CS | FDA UDI | Class I | Active |
| Tinto Progesterone Receptor (EP2) | BSB 2574 (ASR) | FDA UDI | Class I | Active |
| Mohs Mouse/Rabbit PolyDetector DAB HRP Brown Detection System | Kit, 50ml | FDA UDI | Class I | Active |
| Mohs ImmunoDigestor | Ancillary, 50ml | FDA UDI | Class I | Active |
| Progesterone Receptor Control Slides | BSB-9353-CS | FDA UDI | Class I | Active |
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