Identity
- Trade Name
- Para-Pak Ultra EcoFix FDA UDI
- Generic Name
- Faecal specimen container IVD, transport buffer/medium FDA UDI
- Device Name
- Para-Pak Ultra EcoFix is a convenient one vial system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from EcoFix preserved specimen. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI
- Model / Reference
- 981312 FDA UDI
- Description
- Para-Pak Ultra EcoFix is a convenient one vial system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from EcoFix preserved specimen. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI
Identifiers
- Catalog Number
- 981312 FDA UDI
- Primary DI / UDI-DI
- 00840733102493 FDA UDI
- FDA Product Code
- LDX FDA UDI
- GMDN Term
- Faecal specimen container IVD, transport buffer/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Para-Pak Ultra EcoFix by Meridian Bioscience, Inc. — 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
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI a32adbc6-a616-4cac-b9e1-de3c9c6be59c 37 fields · synced May 30, 2026