Identity
- Trade Name
- Para-Pak® Ethyl Acetate EUDAMEDFeKal CON-Trate® Reagent B FDA UDI
- Generic Name
- Faecal parasite isolation kit IVD FDA UDI
- Device Name
- Para-Pak® Ethyl Acetate EUDAMEDBulk Ethyl Acetate used within Meridian's CON-Trate Stool Concentration Systems FDA UDI
- Model / Reference
- FK4318 EUDAMEDFDA UDI
- Description
- Bulk Ethyl Acetate used within Meridian's CON-Trate Stool Concentration Systems FDA UDI
Identifiers
- Catalog Number
- FK4318 FDA UDI
- Primary DI / UDI-DI
- 00840733102059 EUDAMEDFDA UDI
- Basic UDI-DI
- 008407331PARAPAKCLA016ZG EUDAMED
- Direct Marketing DI
- 00840733102059 EUDAMED
- FDA Product Code
- LKS FDA UDI
- EMDN Code
- W0104050101 PARASITOLOGY EXTRACTION REAGENTS EUDAMED
- GMDN Term
- Faecal parasite isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2900 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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® Ethyl Acetate 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 | 008407331PARAPAKCLA016ZG | 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 97dc723e-d6f6-438f-8cd2-1794129aa282 61 fields · synced Jun 20, 2026
- FDA UDI 3353e0ad-f6af-4e43-b621-5d7a0b183203 36 fields · synced May 30, 2026