Para-Pak Modified (Cu) PVA/Formalin

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name: Para-Pak Modified (Cu) PVA/Formalin FDA UDI
Generic Name: Faecal specimen container IVD, fixative FDA UDI
Device Name: Para-Pak PVA based systems provide standardized procedures for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Kit 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: 300812 FDA UDI
Description: Para-Pak PVA based systems provide standardized procedures for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Kit 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: 300812 FDA UDI
Primary DI / UDI-DI: 00840733103049 FDA UDI
FDA Product Code: IFQ FDA UDI
IGG FDA UDI
GMDN Term: Faecal specimen container IVD, fixative 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Faecal specimen container IVD, fixative

Para-Pak Modified (Cu) PVA/Formalin 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 18d927cd-c612-4fdf-b80a-ef3b11144bac 36 fields · synced Jun 8, 2026