Pak Para-C&S/Ultra 10%/Clean

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name: Pak Para-C&S/Ultra 10%/Clean FDA UDI
Generic Name: Faecal specimen container IVD, transport buffer/medium FDA UDI
Device Name: Para-Pak and Para-Pak Ultra 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. Bulk products for preservation of fresh specimens are also available. FDA UDI
Model / Reference: 338812 FDA UDI
Description: Para-Pak and Para-Pak Ultra 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. Bulk products for preservation of fresh specimens are also available. FDA UDI

Identifiers

Catalog Number: 338812 FDA UDI
Primary DI / UDI-DI: 00840733103278 FDA UDI
FDA Product Code: JSM FDA UDI
IGG FDA UDI
FMH FDA UDI
GMDN Term: Faecal specimen container IVD, transport buffer/medium FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2390 FDA UDI
864.4010 FDA UDI
864.3250 FDA UDI
Commercial Distribution: Not 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

Pak Para-C&S/Ultra 10%/Clean by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 85dd5846-166a-451b-8044-227ebe1e4871 37 fields · synced Jun 1, 2026