Identity
- Trade Name
- Platelia FDA UDI
- Generic Name
- Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Platelia Aspergillus Ag FDA UDI
- Model / Reference
- 12014064 FDA UDI
- Description
- Platelia Aspergillus Ag FDA UDI
Identifiers
- Catalog Number
- 12014064 FDA UDI
- Primary DI / UDI-DI
- 03610522189380 FDA UDI
- 510(k) Number
- K093678 FDA UDI
- FDA Product Code
- NOM FDA UDI
- GMDN Term
- Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3040 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)
Platelia by Bio-Rad — 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
- Bio-Rad
Sources (1)
- FDA UDI 33f9bd96-bc42-4870-925f-2b29b0bb405f 38 fields · synced May 30, 2026