Identity
- Trade Name
- Para-Pak EcoFix FDA UDI
- Generic Name
- Faecal specimen container IVD, transport buffer/medium FDA UDI
- Device Name
- Para-Pak/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 the EcoFix preserved specimen. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. Primary DI Number 00840733102400 indicates the innerbox of the device. FDA UDI
- Model / Reference
- 901312 FDA UDI
- Description
- Para-Pak/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 the EcoFix preserved specimen. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. Primary DI Number 00840733102400 indicates the innerbox of the device. FDA UDI
Identifiers
- Catalog Number
- 901312 FDA UDI
- Primary DI / UDI-DI
- 00840733102400 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
- 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
Category: Faecal specimen container IVD, transport buffer/medium
Para-Pak EcoFix by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 0d5ba8d0-12f1-4e1e-bef7-b2dcd02e067e 36 fields · synced May 30, 2026