Identity
- Trade Name
- Mono Mo A-Hu CD64, Fc Gamma Receptor I/APC Cl 10.1 FDA UDI
- Generic Name
- CD64 cell marker IVD, antibody FDA UDI
- Device Name
- Monoclonal Mouse Anti-Human CD64, Fc Gamma Receptor I/APC Clone 10.1 FDA UDI
- Model / Reference
- C7278 FDA UDI
- Description
- Monoclonal Mouse Anti-Human CD64, Fc Gamma Receptor I/APC Clone 10.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572018896 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- CD64 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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: CD64 cell marker IVD, antibody
Mono Mo A-Hu CD64, Fc Gamma Receptor I/APC Cl 10.1 by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as CD64 cell marker IVD, antibody.
- CD64 FITC — IQ Products B.V. · Class I
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- Human CD64 R-PE Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- CD64 PURE — IQ Products B.V. · Class I
- CD64 CyQ — IQ Products B.V. · Class I
- Human CD64 APC Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Human CD64 FITC Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Horizon — BECTON DICKINSON AND COMPANY · 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
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI 012543cd-7b5d-4382-a944-3334f55fdf84 36 fields · synced May 30, 2026