Para-Pak SAF / Clean / C&S

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name: Para-Pak SAF / Clean / C&S FDA UDI
Generic Name: Faecal specimen container IVD, fixative FDA UDI
Device Name: Para-Pak systems are systems for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use 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: 330384 FDA UDI
Description: Para-Pak systems are systems for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use 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: 330384 FDA UDI
Primary DI / UDI-DI: 00840733103216 FDA UDI
FDA Product Code: IGG FDA UDI
JSM FDA UDI
FMH FDA UDI
GMDN Term: Faecal specimen container IVD, fixative FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4010 FDA UDI
866.2390 FDA UDI
864.3250 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 SAF / Clean / C&S 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 b41bdc2f-e6e6-4e34-899f-a6dbbd136751 36 fields · synced Jun 8, 2026