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CD38 (SP149) Rabbit Monoclonal Primary Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 760-4785
Identity
- Trade Name
- anti-CD38 (SP149) Rabbit Monoclonal Primary Antibody EUDAMEDCD38 (SP149) Rabbit Monoclonal Primary Antibody FDA UDI
- Generic Name
- CD38 cell marker IVD, antibody FDA UDI
- Device Name
- anti-CD38 (SP149) Rabbit Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 760-4785 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683101413 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831760-47853B EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- CD38 cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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: CD38 cell marker IVD, antibody
CD38 (SP149) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as CD38 cell marker IVD, antibody.
- Rabbit Monoclonal Anti-Human CD38 Antibody, EP135 — EPITOMICS, INC. · Class I
- ANTI-CD38 — Biogenex Laboratories, Inc. · Class I
- Mono Mo A-Hu CD38/FITC Cl AT13/5 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- ANTI-CD38 — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human CD38 Antibody, EP135 — EPITOMICS, INC. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Mouse Monoclonal Anti-Human CD38(MX044) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Horizon — BECTON DICKINSON AND COMPANY · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (2)
- FDA UDI df06c30a-d7ca-4387-a8dd-e342ab92d293 33 fields · synced Jun 19, 2026
- EUDAMED 51a5a0fb-0130-4c5a-9f13-bb4490792e8a 61 fields · synced Jun 19, 2026