Herpes Simplex Virus I Rabbit Polyclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Herpes Simplex Virus I Rabbit Polyclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Herpes Simplex Virus I Rabbit Polyclonal Antibody EUDAMED
- Model / Reference
- 361A-1X series EUDAMED361A-14 EUDAMED361A-18 EUDAMED361A-16 EUDAMED361A-17-ASR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683138587 EUDAMED00841683138709 EUDAMED00841683138648 EUDAMED00841683138686 FDA UDI
- Basic UDI-DI
- 008416831361A-1AV EUDAMED
- FDA Product Code
- MVU FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4020 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: Assay development analyte-specific reagent IVD
Herpes Simplex Virus I Rabbit Polyclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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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 (4)
- FDA UDI 70ff13e8-45ac-4999-abaa-87eb4dec7356 33 fields · synced Sep 30, 2026
- EUDAMED b89272d4-469e-43ce-bc38-efb855bd2b50 61 fields · synced Jul 8, 2026
- EUDAMED d64c2952-5ce9-4890-9633-5f4fa9dc03ef 61 fields · synced Jul 14, 2026
- EUDAMED c26be892-54be-4ec7-8e18-ef8aa329cf0d 61 fields · synced Jul 29, 2026