Identity
- Trade Name
- Mono Mo a Hu CD33/RPE, Cl WM-54 FDA UDI
- Generic Name
- CD33 cell marker IVD, antibody FDA UDI
- Device Name
- Monoclonal Mouse Anti-Human CD33/RPE Clone WM-54 FDA UDI
- Model / Reference
- R0745 FDA UDI
- Description
- Monoclonal Mouse Anti-Human CD33/RPE Clone WM-54 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572516224 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- CD33 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: CD33 cell marker IVD, antibody
Mono Mo a Hu CD33/RPE, Cl WM-54 by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as CD33 cell marker IVD, antibody.
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- CD33 (PWS44) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- CD33 (SP266) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- CD33 (PWS44) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI 87163d46-eb9b-49b9-9acd-aa4d6e8f119c 36 fields · synced May 30, 2026