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CD1a (EP3622) Rabbit Monoclonal Primary Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 101R-15Model 101R-1X seriesRef 101R-17
Identity
- Trade Name
- CD1a (EP3622) Rabbit Monoclonal Primary Antibody EUDAMEDFDA UDI
- Generic Name
- CD1a cell marker IVD, antibody FDA UDI
- Device Name
- CD1a (EP3622) Rabbit Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 101R-17 EUDAMEDFDA UDI101R-15 EUDAMEDFDA UDI101R-1X series EUDAMED101R-14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683122951 EUDAMEDFDA UDI00841683122937 EUDAMEDFDA UDI00841683122920 FDA UDI
- Basic UDI-DI
- 008416831101R-1AN EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- CD1a 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
No
FDA UDI
Category: CD1a cell marker IVD, antibody
CD1a (EP3622) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as CD1a cell marker IVD, antibody.
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- BOND — Leica Biosystems Newcastle, Limited · Class I
- ANTI-CD1A — Biogenex Laboratories, Inc. · 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 (5)
- FDA UDI 3e8857ba-03f8-4dd9-b7cc-a6b68c0d0ef7 33 fields · synced Jul 14, 2026
- FDA UDI f78c7fc1-bb99-4a5c-aff8-087b43429827 33 fields · synced May 25, 2026
- FDA UDI ea907d4f-743a-46a9-9739-0f6cfc6f9e02 33 fields · synced May 30, 2026
- EUDAMED 3c9d7802-5c33-45f9-81b2-81cdd7b9ced5 61 fields · synced Jul 10, 2026
- EUDAMED ecac5927-13b0-4f56-984b-f25344cff320 61 fields · synced Jul 14, 2026