Identity
- Trade Name
- MERIFLUOR Pneumocystis FDA UDI
- Generic Name
- Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
- Device Name
- MERIFLUOR Pneumocystis is an in vitro direct immunofluorescent detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens. FDA UDI
- Model / Reference
- 222030 FDA UDI
- Description
- MERIFLUOR Pneumocystis is an in vitro direct immunofluorescent detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens. FDA UDI
Identifiers
- Catalog Number
- 222030 FDA UDI
- Primary DI / UDI-DI
- 00840733101106 FDA UDI
- FDA Product Code
- LYF FDA UDI
- GMDN Term
- Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3780 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
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: Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)
MERIFLUOR Pneumocystis by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT).
- MONOFLUO — Bio-Rad Laboratories · Class II
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
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 4e952ab4-4ef9-477f-b6ec-d3d374297d9d 36 fields · synced May 30, 2026