Identity
- Trade Name
- Para-Pak EcoFix / Clean FDA UDI
- Generic Name
- Faecal specimen container IVD, transport buffer/medium FDA UDI
- Device Name
- Para-Pak EcoFix is a convenient system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from the EcoFix preserved specimen. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI
- Model / Reference
- 301312 FDA UDI
- Description
- Para-Pak EcoFix is a convenient system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from the EcoFix preserved specimen. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI
Identifiers
- Catalog Number
- 301312 FDA UDI
- Primary DI / UDI-DI
- 00840733102622 FDA UDI
- FDA Product Code
- FMH FDA UDILDX FDA UDI
- GMDN Term
- Faecal specimen container IVD, transport buffer/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI864.4010 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: Faecal specimen container IVD, transport buffer/medium
Para-Pak EcoFix / Clean by Meridian Bioscience, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (2)
- FDA UDI 9e2a7f73-2d01-48e4-90c5-50f71edc580b 36 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced May 28, 2026