Identity
- Trade Name
- CMV (DDG9/CCH2) Mouse Monoclonal Antibody FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Model / Reference
- 213M-14-ASR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683126850 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Assay development analyte-specific reagent IVD
CMV (DDG9/CCH2) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Assay development analyte-specific reagent IVD.
- PE/Dazzle™ 594 anti-human CD38 — BIOLEGEND, INC. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Beckmancoulter — Immunotech Corp. · Class I
- Beckmancoulter — Immunotech Corp. · Class I
- MetaSystems Probes — MetaSystems Probes GmbH · Class I
- Helicobacter Pylori (EP279) — BIO SB, INC. · Class I
- CytoCell — Cytocell, Ltd. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (2)
- FDA UDI c97bae2a-fe03-4d1b-bb5f-3f155074da6e 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026