Identity
- Trade Name
- Para-Pak® C&S EUDAMEDPara-Pak C&S FDA UDI
- Generic Name
- Faecal specimen container IVD, transport buffer/medium FDA UDI
- Device Name
- Para-Pak® C&S EUDAMEDThe Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation. FDA UDI
- Model / Reference
- 900612 EUDAMEDFDA UDI
- Description
- The Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation. FDA UDI
Identifiers
- Catalog Number
- 900612 FDA UDI
- Primary DI / UDI-DI
- 00840733102011 EUDAMEDFDA UDI
- Basic UDI-DI
- 008407331PARAPAKCLA003Z7 EUDAMED
- Direct Marketing DI
- 00840733102011 EUDAMED
- 510(k) Number
- K792712 FDA UDI
- FDA Product Code
- JSM FDA UDI
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
- GMDN Term
- Faecal specimen container IVD, transport buffer/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Para-Pak® C&S by Meridian Bioscience, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 008407331PARAPAKCLA003Z7 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience Inc.
- EUDAMED SRN
- US-MF-000044096
- Authorised Representative
- Meridian Bioscience Europe S.r.l. IT-AR-000010460
Sources (2)
- EUDAMED f3559b4a-c791-4539-aa52-65c2aad31bcd 61 fields · synced Jun 1, 2026
- FDA UDI a26d1607-c756-43e9-b007-90eaee4738ea 37 fields · synced May 30, 2026