Identity
- Trade Name
- Horizon FDA UDI
- Generic Name
- CD16 cell marker IVD, antibody FDA UDI
- Device Name
- BD Horizon CD16 (3G8) BV786 ASR FDA UDI
- Model / Reference
- 664531 FDA UDI
- Description
- BD Horizon CD16 (3G8) BV786 ASR FDA UDI
Identifiers
- Catalog Number
- 664531 FDA UDI
- Primary DI / UDI-DI
- 00382906645319 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- CD16 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: CD16 cell marker IVD, antibody
Horizon by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Becton Dickinson And Company
Sources (1)
- FDA UDI d1e36896-bc3a-4e52-901f-8eb13b19b77b 36 fields · synced Jun 6, 2026