Identity
- Trade Name
- Tinto S100A6 RMab FDA UDI
- Generic Name
- S100 protein IVD, antibody FDA UDI
- Device Name
- Anti S100A6 is rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
- Model / Reference
- Predilute, 7 ml FDA UDI
- Description
- Anti S100A6 is rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Identifiers
- Catalog Number
- BSB 3177 FDA UDI
- Primary DI / UDI-DI
- B502BSB31770 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- S100 protein IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: S100 protein IVD, antibody
Tinto S100A6 RMab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as S100 protein IVD, antibody.
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- Anti-S100P — Biogenex Laboratories, Inc. · Class I
- IHC — Slmp, LLC · Class I
- S100 Protein [4C4.9] (M) — BIOCARE MEDICAL, LLC · Class I
- S100A1 (EP184) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- IHC — Slmp, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI ee818ec2-d417-4b0e-a822-e9b27ea749b4 34 fields · synced May 31, 2026