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Para-Pak EcoFix

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Para-Pak EcoFix FDA UDI
Generic Name
Faecal specimen container IVD, transport buffer/medium FDA UDI
Device Name
Bulk stool preservation reagent, Component of Para-Pak EcoFix FDA UDI
Model / Reference
401301 FDA UDI
Description
Bulk stool preservation reagent, Component of Para-Pak EcoFix FDA UDI

Identifiers

Catalog Number
401301 FDA UDI
Primary DI / UDI-DI
00840733102042 FDA UDI
FDA Product Code
LDX 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
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

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 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 c5011cde-0c0e-40a4-b327-a14a6635267f 36 fields · synced Jun 1, 2026