Identity
- Trade Name
- Anti-RSV ELISA (IgM) FDA UDI
- Generic Name
- Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- EI 2670-9601 M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016028246 FDA UDI
- FDA Product Code
- MCE FDA UDI
- GMDN Term
- Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3480 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
Anti-RSV ELISA (IgM) by EUROIMMUN Medizinische Labordiagnostika AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 f38199cf-6ba5-4731-98a5-5d0aafcd32dd 34 fields · synced May 30, 2026