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Para-Pak Macro-CON

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Para-Pak Macro-CON FDA UDI
Generic Name
Faecal parasite isolation kit IVD FDA UDI
Device Name
Para-Pak Macro-CON is a system for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. The filtration unit is designed to be used directly with the Para-Pak specimen collection vial. This creates a completely closed system, minimizing exposure of the user to potentially infectious agents. Macro-CON concentration utilizes the entire contents of the Para-Pak specimen collection vial, reducing variation due to specimen sampling. This is of particular advantage to the clinical parasitologist when a small number of organisms may be present in a large volume of stool. FDA UDI
Model / Reference
970120 FDA UDI
Description
Para-Pak Macro-CON is a system for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. The filtration unit is designed to be used directly with the Para-Pak specimen collection vial. This creates a completely closed system, minimizing exposure of the user to potentially infectious agents. Macro-CON concentration utilizes the entire contents of the Para-Pak specimen collection vial, reducing variation due to specimen sampling. This is of particular advantage to the clinical parasitologist when a small number of organisms may be present in a large volume of stool. FDA UDI

Identifiers

Catalog Number
970120 FDA UDI
Primary DI / UDI-DI
00840733102028 FDA UDI
510(k) Number
K860034 FDA UDI
FDA Product Code
LKS FDA UDI
GMDN Term
Faecal parasite isolation kit IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2900 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 parasite isolation kit IVD

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

Similar devices

Also classified as Faecal parasite isolation kit IVD.

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 f258bd59-14cc-4586-816b-d0756c2d8076 37 fields · synced May 30, 2026