Identity
- Trade Name
- Biotrin Parvovirus B19 IgM EIA FDA UDI
- Generic Name
- Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- V6191MUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- EBTRV619IMUS09 FDA UDI
- GMDN Term
- Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Biotrin Parvovirus B19 IgM EIA by Diasorin Ireland Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Diasorin Ireland Limited
Sources (1)
- FDA UDI 1a8c255a-6d2b-42b1-be71-8617b5b02f8e 32 fields · synced Jun 8, 2026