Identity
- Trade Name
- CD33 (SP266) Rabbit Monoclonal Primary Antibody FDA UDI
- Generic Name
- CD33 cell marker IVD, antibody FDA UDI
- Model / Reference
- 760-4952 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683101642 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- CD33 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CD33 cell marker IVD, antibody
CD33 (SP266) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD33 cell marker IVD, antibody.
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Mono Mo A-Hu CD33/FITC Cl WM-54 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Mono Mo a Hu CD33/RPE, Cl WM-54 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- CD33 — BIOCARE MEDICAL, LLC · Class I
- Novocastra — Leica Biosystems Newcastle, 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
- Cell Marque Corporation
Sources (1)
- FDA UDI d0f39666-5a29-4f1f-b025-d8ea4b48aac9 33 fields · synced May 29, 2026