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Para-Pak C&S

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Para-Pak C&S FDA UDI
Generic Name
Faecal specimen container IVD, transport buffer/medium FDA UDI
Device Name
The Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens 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
900612 FDA UDI
Description
The Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens 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
900612 FDA UDI
Primary DI / UDI-DI
00840733102714 FDA UDI
510(k) Number
K792712 FDA UDI
FDA Product Code
JSM 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
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Faecal specimen container IVD, transport buffer/medium

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

Similar devices

Also classified as Faecal specimen container IVD, transport buffer/medium.

Cleared under the same submission

K792712 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI 125a47c9-7dbc-4e09-9b07-b9c89978c8de 37 fields · synced Jun 8, 2026