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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 18 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet | 50 ml each (500 tests) | FDA UDI | Class I | Active |
| Cytokeratin 35BH11 Control Slides | BSB-9141-CS | FDA UDI | Class I | Active |
| Mouse/Rabbit PolyDetector DAB HRP Brown Detection System | 1000 ml each | FDA UDI | Class I | Active |
| Adenovirus Control Slides | BSB-9006-CS | FDA UDI | Class I | Active |
| Tinto Estrogen Receptor (BSB-1) | BSB 2741 (ASR) | FDA UDI | Class I | Active |
| Tinto Cytokeratin 17, RMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| Tinto Hepatitis B Virus Surface Antigen , MMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| CD7 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Estrogen Receptor RMab Control Slides | Conrol Slides, 5 | FDA UDI | Class I | Active |
| Cytokeratin 8 & 18 RMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| PolyDetector Alk Blue Ready-To-Use | 200 ml | FDA UDI | Class I | Active |
| PSAP Control Slides | BSB-9357-CS | FDA UDI | Class I | Active |
| Vimentin control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto S100 Beta, RMab | Predilute, 15 ml | FDA UDI | Class I | Active |
| Tinto c-Myc MMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| Tinto Cyclin B1, RMab | Predilute, 7 ml | FDA UDI | Class I | Active |
| S100A6 RMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| Cytokeratin 16 RMab | Concentrate, 1 ml | FDA UDI | Class I | Active |
| Mouse/Rabbit PolyDetector Plus AEC HRP Red Detection System | 1000 ml each | FDA UDI | Class I | Active |
| CD123 IL-3Ra Control Slides | BSB-9064-CS | FDA UDI | Class I | Active |
| Cytokeratin 5 & 6 Control Slides | BSB-9145-CS | FDA UDI | Class I | Active |
| Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet Detection System | 1000 ml each (10000 tests) | FDA UDI | Class I | Active |
| PolyDetector AP Blocker | 100 ml | FDA UDI | Class I | Active |
| PolyDetector Alk Scarlet | 15 ml, | FDA UDI | Class I | Active |
| Satb2 (rbt-Satb2) | BSB-3848-01 | FDA UDI | Class I | Active |
| PD-L1/CD274 control slides | control slides.5 | FDA UDI | Class I | Active |
| Ox-40/Cd134 (bsb-90) | BSB 3125 (ASR) | FDA UDI | Class I | Active |
| IgG control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| PolyDetector Liquid DAB HRP Brown kit | 5000 tests | FDA UDI | Class I | Active |
| c-Myc control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| HER2 neu Phospho RMab | Concentrate, 1 ml | FDA UDI | Class I | Active |
| Cytomegalovirus MMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| CD45RO control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto EGFR Phospho (EP11) | BSB 6717 (ASR) | FDA UDI | Class I | Active |
| Tinto Smoothelin | Predilute, 15 ml | FDA UDI | Class I | Active |
| Tinto CD146/MUC18/Mel-CAM, MMab | Predilute, 3 ml | FDA UDI | Class I | Active |
| Tinto Herpes Simplex Virus I (10A3) | BSB 2684 (ASR) | FDA UDI | Class I | Active |
| Mouse/Rabbit PolyDetector HRP Label | Ready-to-use, 100 ml each | FDA UDI | Class I | Active |
| Alpha Synuclein control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| EBV Cell Line Array (2-core: Positive and Negative) Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| PolyDetector Alk Scarlet | 100 ml | FDA UDI | Class I | Active |
| Mouse/Rabbit AmpliDetector Plus FITC | BSB-0359-15 | FDA UDI | Class I | Active |
| PD-1/CD279 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| PolyDetector Alk Brown Ready-To-Use | 15 ml | FDA UDI | Class I | Active |
| ChromoProtector | 100 ml | FDA UDI | Class I | Active |
| Tinto Prolactin (RBT-PRL) | BSB-3845-15 | FDA UDI | Class I | Active |
| Tinto Herpes Simplex Virus II (BSB-116) | BSB 3464 (ASR) | FDA UDI | Class I | Active |
| S100A8/MRP8, RMab | Concentrate, 1 ml | FDA UDI | Class I | Active |
| Tinto Varicella Zoster Virus (SG1, SG1-1, SG2-2E6, SG3, SG4, NCP-1 & IE-62) | BSB-3810-15-ASR | FDA UDI | Class I | Active |
| Myeloperoxidase/MPO (BSB-180) | BSB-3828-01 | FDA UDI | Class I | Active |
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