Identity
- Trade Name
- Para-Pak 10% Formalin Fixative FDA UDI
- Generic Name
- Faecal specimen container IVD, transport buffer/medium FDA UDI
- Device Name
- Para-Pak based systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transportation. FDA UDI
- Model / Reference
- 900412 FDA UDI
- Description
- Para-Pak based systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transportation. FDA UDI
Identifiers
- Catalog Number
- 900412 FDA UDI
- Primary DI / UDI-DI
- 00840733102707 FDA UDI
- FDA Product Code
- IGG 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
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 10% Formalin Fixative by Meridian Bioscience, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Faecal specimen container IVD, transport buffer/medium.
- CALEX® Cap, 50 pieces — Bühlmann Laboratories AG
- IDK Extract® — IMMUNDIAGNOSTIK, INC. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- IDK Extract® — IMMUNDIAGNOSTIK, INC. · Class I
- CALEX® Cap, 200 pieces — Bühlmann Laboratories AG
- CALEX Cap — Bühlmann Laboratories AG
- IDK Extract® — IMMUNDIAGNOSTIK, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (2)
- FDA UDI 9411a905-878d-469f-a051-79dfcd06b08f 36 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced May 29, 2026