Identity
- Trade Name
- Anti-PLA2R IFA FDA UDI
- Generic Name
- Phospholipase A2 receptor (PLA2R) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- FA 1254-1010-50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016095798 FDA UDI
- 510(k) Number
- DEN140002 FDA UDI
- FDA Product Code
- PGV FDA UDI
- GMDN Term
- Phospholipase A2 receptor (PLA2R) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5780 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
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: Phospholipase A2 receptor (PLA2R) antibody IVD, kit, fluorescent immunoassay
Anti-PLA2R IFA by EUROIMMUN Medizinische Labordiagnostika AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phospholipase A2 receptor (PLA2R) antibody IVD, kit, fluorescent immunoassay.
- Anti-PLA2R IFA — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- Anti-PLA2R IFA — EUROIMMUN Medizinische Labordiagnostika AG · Class II
Cleared under the same submission
DEN140002 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 8c38aa1d-acca-475d-8e44-45fbfba9a916 34 fields · synced May 31, 2026