Identity
- Trade Name
- Para-Pak® SVT EUDAMEDPara-Pak SVT FDA UDI
- Generic Name
- Faecal specimen container IVD, transport buffer/medium FDA UDI
- Device Name
- Para-Pak® SVT EUDAMEDPara-Pak SVT (Single Vial Transport) is a convenient one-vial system for the routine collection, transportation,preservation and examination of stool specimens for intestinal parasites. Stool specimens preserved in Para-Pak SVT can be used for direct examination, concentration, permanent stain and in fecal immunoassays. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI
- Model / Reference
- 901612 EUDAMEDFDA UDI
- Description
- Para-Pak SVT (Single Vial Transport) is a convenient one-vial system for the routine collection, transportation,preservation and examination of stool specimens for intestinal parasites. Stool specimens preserved in Para-Pak SVT can be used for direct examination, concentration, permanent stain and in fecal immunoassays. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI
Identifiers
- Catalog Number
- 901612 FDA UDI
- Primary DI / UDI-DI
- 00840733102073 EUDAMEDFDA UDI
- Basic UDI-DI
- 008407331PARAPAKCLA010Z4 EUDAMED
- Direct Marketing DI
- 00840733102073 EUDAMED
- FDA Product Code
- LDX FDA UDI
- EMDN Code
- W0104050101 PARASITOLOGY EXTRACTION REAGENTS EUDAMED
- GMDN Term
- Faecal specimen container IVD, transport buffer/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 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
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® SVT 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 | 008407331PARAPAKCLA010Z4 | 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 406dfe80-69a4-4baf-9b62-48ca478c26da 61 fields · synced May 30, 2026
- FDA UDI b2070e0d-dae3-4abc-b43a-782e95534b80 36 fields · synced May 30, 2026