Identity
- Trade Name
- MERIFLUOR Cryptosporidium/Giardia FDA UDI
- Generic Name
- Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
- Device Name
- MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material. FDA UDI
- Model / Reference
- 250050 FDA UDI
- Description
- MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material. FDA UDI
Identifiers
- Catalog Number
- 250050 FDA UDI
- Primary DI / UDI-DI
- 00840733101113 FDA UDI
- FDA Product Code
- MHI FDA UDI
- GMDN Term
- Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3220 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: Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT)
MERIFLUOR Cryptosporidium/Giardia by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT).
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 f4eccf92-c41b-4e7c-acc2-d900686776c3 36 fields · synced May 30, 2026