Identity
- Trade Name
- Anti-Mumps virus IFA (IgM) FDA UDI
- Generic Name
- Mumps virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- FI 2630-1005 M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016057512 FDA UDI
- FDA Product Code
- GRA FDA UDI
- GMDN Term
- Mumps virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3380 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
The Anti-Mumps virus IFA (IgM) medical device is a highly sensitive and specific fluorescent immunoassay kit used for the detection of IgM antibodies to Mumps virus in clinical specimens. It is designed for laboratory use and requires proper handling, storage, and labeling to ensure accurate and reliable results.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 7632f238-4fed-4195-885e-b8a7925a1b83 34 fields · synced Oct 6, 2026