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Para-Pak EcoFix/Clean

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Para-Pak EcoFix/Clean FDA UDI
Generic Name
Faecal specimen container IVD, transport buffer/medium FDA UDI
Device Name
Para-Pak/Para-Pak Ultra EcoFix is a convenient two-vial system for the routine collection, transportation, and preservation and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from the EcoFix preserved specimen. The fixative affords and excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI
Model / Reference
301312 FDA UDI
Description
Para-Pak/Para-Pak Ultra EcoFix is a convenient two-vial system for the routine collection, transportation, and preservation and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from the EcoFix preserved specimen. The fixative affords and excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI

Identifiers

Catalog Number
301312 FDA UDI
Primary DI / UDI-DI
00840733103056 FDA UDI
FDA Product Code
LDX 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
864.4010 FDA UDI
864.3250 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

Yes

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 EcoFix/Clean 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.

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 f1d69e95-f4fd-45af-b66d-c8f41af837a0 36 fields · synced May 30, 2026