Identity
- Trade Name
- Light Diagnostics PCP DFA Reagent FDA UDI
- Generic Name
- Pneumocystis jirovecii antigen IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Light Diagnostics PCP DFA Reagent FDA UDI
- Model / Reference
- 5195 FDA UDI
- Description
- Light Diagnostics PCP DFA Reagent FDA UDI
Identifiers
- Catalog Number
- 5195 FDA UDI
- Primary DI / UDI-DI
- 04053252730351 FDA UDI
- 510(k) Number
- K992252 FDA UDI
- FDA Product Code
- LYF FDA UDI
- GMDN Term
- Pneumocystis jirovecii antigen IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3780 FDA UDI
- Commercial Distribution
- Not 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
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
Light Diagnostics PCP DFA Reagent by Emd Millipore Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Emd Millipore Corporation
Sources (1)
- FDA UDI 22d9e691-b157-4e5b-8d35-8c30431db8a6 37 fields · synced Jun 8, 2026