Identity
- Trade Name
- LIAISON® Biotrin Parvovirus B19 IgG Plus FDA UDI
- Generic Name
- Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Italy manufactured kit. FDA UDI
- Model / Reference
- 311550 FDA UDI
- Description
- Italy manufactured kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056771104029 FDA UDI
- PMA Number
- P220034 FDA UDI
- FDA Product Code
- MYL FDA UDI
- GMDN Term
- Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
Yes
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
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 G (IgG) antibody IVD, kit, chemiluminescent immunoassay
LIAISON® Biotrin Parvovirus B19 IgG Plus by Diasorin Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P220034 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Diasorin Inc.
Sources (1)
- FDA UDI 93f0b88d-904d-4676-89db-b7792d8d9762 34 fields · synced May 30, 2026