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CD4 (SP35) Rabbit Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 104R-15Model 104R-1X seriesRef 104R-14Ref 104R-18
Identity
- Trade Name
- CD4 (SP35) Rabbit Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- CD4 cell marker IVD, antibody FDA UDI
- Device Name
- CD4 (SP35) Rabbit Monoclonal Antibody EUDAMED
- Model / Reference
- 104R-15 EUDAMEDFDA UDI104R-14 EUDAMEDFDA UDI104R-18 EUDAMEDFDA UDI104R-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683122210 EUDAMEDFDA UDI00841683122203 EUDAMEDFDA UDI00841683123217 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831104R-1BB EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- CD4 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: CD4 cell marker IVD, antibody
CD4 (SP35) Rabbit Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (6)
- FDA UDI 27ef559f-e98b-4ed6-acb1-eef010cc64ad 33 fields · synced Jul 27, 2026
- FDA UDI 40b4d441-87a5-40c2-8a8a-89f1acdb20a7 33 fields · synced May 30, 2026
- FDA UDI d361ba6c-18cc-4313-be33-d1ec9d85707f 33 fields · synced May 30, 2026
- EUDAMED 49bf3fb9-8377-4274-9645-0f11603fb8fc 61 fields · synced Jul 21, 2026
- EUDAMED 9140e963-23ee-4010-af40-3c15d55dec28 61 fields · synced Jul 27, 2026
- EUDAMED 28ca71e5-5e5f-4708-9c1a-698e82b29c7c 61 fields · synced Jul 27, 2026