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 44 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Glucagon RPab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| PolyDetector HRP Green kit | 150 Tests | FDA UDI | Class I | Active |
| CD117 Control Slides | BSB-9061-CS | FDA UDI | Class I | Active |
| Bax Control Slides | BSB-9026-CS | FDA UDI | Class I | Active |
| Hemoglobin A RMab | Concentrate, 1 ml | FDA UDI | Class I | Active |
| Tinto Estrogen Receptor (RM292) | BSB-3765-7-ASR | FDA UDI | Class I | Active |
| Tinto S100A6 RMab | Predilute, 7 ml | FDA UDI | Class I | Active |
| Cytokeratin 16 RMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| Myoglobin RPab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| Herpes Simplex Virus II Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| PTEN MMab | Concentrate, 1 ml | FDA UDI | Class I | Active |
| Hhv-8 (13b10) | BSB 5649 (ASR) | FDA UDI | Class I | Active |
| Granzyme B Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto Lambda, RPab | Predilute, 15 ml | FDA UDI | Class I | Active |
| TintoDeparaffinator Hot Rinse 20X | 1000 ml | FDA UDI | Class I | Active |
| EGFR Phospho (EP11) | BSB 6721 (ASR) | FDA UDI | Class I | Active |
| PAX-5 Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Nestin Control Slides | BSB-9303-CS | FDA UDI | Class I | Active |
| Tinto HHV-8 (RBT-HHV8) | BSB-3778-3-ASR | FDA UDI | Class I | Active |
| Cytokeratin 5 & ERG, RMab | Concentrate, 0.5 ml | FDA UDI | Class I | Active |
| IMP-3 / 1GF2BP3 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Cytokeratin 5 & 14 RMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| Tinto CD19 RMab | Predilute, 15 ml | FDA UDI | Class I | Active |
| Neurofilament control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto Helicobacter Pylori (EP279) | BSB 3279 (ASR) | FDA UDI | Class I | Active |
| p57 control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| FOXP1 Control Slides | BSB-9185-CS | FDA UDI | Class I | Active |
| ImmunoDetector Biotin Blocker | 15 ml | FDA UDI | Class I | Active |
| p40 Control Slides | BSB-9324-CS | FDA UDI | Class I | Active |
| Progesterone Receptor control slides | Control Slides, 5 | FDA UDI | Class I | Active |
| Tinto FOXA1 / HNF-3A, RPab | Predilute, 15ml | FDA UDI | Class I | Active |
| Methyl Green Counterstainer | 100 ml | FDA UDI | Class I | Active |
| Tinto EGFR Phospho (EP11) | BSB 6716 (ASR) | FDA UDI | Class I | Active |
| Tinto SV40 (Pab101) | BSB 2230 (ASR) | FDA UDI | Class I | Active |
| Helicobacter Pylori (EP279) | BSB 3284 (ASR) | FDA UDI | Class I | Active |
| PSA RMab | Concentrate, 0.1 ml | FDA UDI | Class I | Active |
| Tinto PSAP (RBT-PSAP) | BSB-3846-3 | FDA UDI | Class I | Active |
| Tinto CD4 (BSB-179) | BSB-3818-15 | FDA UDI | Class I | Active |
| ERCC1 RMab Control Slides | Control Slides, 5 | FDA UDI | Class I | Active |
| SOX-2 Control Slides | BSB-9384-CS | FDA UDI | Class I | Active |
| FSH Control Slides | BSB-9187-CS | FDA UDI | Class I | Active |
| EGFR Phospho (EP11) | BSB 6720 (ASR) | FDA UDI | Class I | Active |
| NSE Control Slides | BSB-9312-CS | FDA UDI | Class I | Active |
| Cytokeratin 7 & CDX2 Control Slides | BSB-9150-CS | FDA UDI | Class I | Active |
| ImmunoDNA Digestor | 1000 ml | FDA UDI | Class I | Active |
| Stat6 (rm473) | BSB-3809-01 | FDA UDI | Class I | Active |
| Mouse/Rabbit PolyDetector Plus DAB HRP Brown Detection System | 1000 ml each | FDA UDI | Class I | Active |
| PolyDetector HRP Black kit | 1000 Tests | FDA UDI | N/A | Active |
| Hematoxylin Counterstainer | 50 ml | FDA UDI | Class I | Active |
| Tinto Herpes Simplex Virus I (Polyclonal) | BSB 2428 (ASR) | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.