Identity
- Trade Name
- Tinto Langerin / CD207 RMab FDA UDI
- Generic Name
- CD207 cell marker IVD, antibody FDA UDI
- Device Name
- Langerin is a 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, 15 ml FDA UDI
- Description
- Langerin is a 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 3372 FDA UDI
- Primary DI / UDI-DI
- B502BSB33720 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- CD207 cell marker 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: CD207 cell marker IVD, antibody
Tinto Langerin / CD207 RMab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD207 cell marker IVD, antibody.
- Rabbit Monoclonal Anti-Human Langerin (CD207), EP349 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Langerin (CD207), EP349 — EPITOMICS, INC. · Class I
- Langerin (12D6) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Langerin (12D6) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Mouse Monoclonal Anti-Human Langerin (CD207)(MX121) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Langerin (12D6) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Langerin (12D6) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Langerin (CD207), EP349 — EPITOMICS, INC. · 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 9530fb57-62d2-4a8e-b0dd-4b6641924a16 34 fields · synced May 31, 2026