Identity
- Trade Name
- Horizon FDA UDI
- Generic Name
- CD79b cell marker IVD, antibody FDA UDI
- Device Name
- BD Horizon™ CD79b (SN8) APC-R700 FDA UDI
- Model / Reference
- 657703 FDA UDI
- Description
- BD Horizon™ CD79b (SN8) APC-R700 FDA UDI
Identifiers
- Catalog Number
- 657703 FDA UDI
- Primary DI / UDI-DI
- 00382906577030 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- CD79b cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CD79b cell marker IVD, antibody
Horizon by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD79b cell marker IVD, antibody.
- Mono Mo A-Hu CD79ß/FITC Cl SN8 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Rabbit Monoclonal Anti-Human CD79b Antibody, EP214 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human CD79b Antibody, EP214 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human CD79b Antibody, EP214 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human CD79b Antibody, EP214 — EPITOMICS, INC. · Class I
- IHC — Slmp, LLC · Class I
- Mono Mo a Hu CD79ß/RPE, Cl SN8 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI d97322a5-1039-411e-a346-585d59603555 36 fields · synced May 29, 2026