CD71 (MRQ-48) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- CD71 (MRQ-48) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- CD71 cell marker IVD, antibody FDA UDI
- Device Name
- CD71 (MRQ-48) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 171M-95 EUDAMEDFDA UDI171M-96 EUDAMEDFDA UDI171M-98 EUDAMEDFDA UDI171M-9X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683125402 EUDAMEDFDA UDI00841683125419 EUDAMEDFDA UDI00841683125433 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831171M-9CS EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- CD71 cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class B 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: CD71 cell marker IVD, antibody
CD71 (MRQ-48) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as CD71 cell marker IVD, antibody.
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- Human CD71 R-PE Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 (6)
- FDA UDI 94345968-901c-4b0f-a322-24b8f1e2ffe8 33 fields · synced Jul 14, 2026
- FDA UDI f9c42760-5cbb-4b4f-b687-afd71cdeb3ca 33 fields · synced May 30, 2026
- FDA UDI c1acd67a-342a-4c60-af74-37c2b7b23d1f 33 fields · synced May 30, 2026
- EUDAMED fc86f0ac-e03e-447c-a72e-16cd03a7acc8 61 fields · synced Jul 9, 2026
- EUDAMED 7beb20bf-9334-4541-8920-662ca03e4a15 61 fields · synced Jul 10, 2026
- EUDAMED 14c60160-23ad-4caf-bfb0-ba9c303b46ac 61 fields · synced Jul 14, 2026