← Back to catalogue

Para-Pak LV-PVA / Ultra 10% Formalin

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Para-Pak LV-PVA / Ultra 10% Formalin FDA UDI
Generic Name
Faecal specimen container IVD, fixative FDA UDI
Device Name
Para-Pak 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. FDA UDI
Model / Reference
380112 FDA UDI
Description
Para-Pak 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. FDA UDI

Identifiers

Catalog Number
380112 FDA UDI
Primary DI / UDI-DI
00840733102967 FDA UDI
FDA Product Code
IGG FDA UDI
IFQ FDA UDI
GMDN Term
Faecal specimen container IVD, fixative FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 FDA UDI
Commercial Distribution
Not 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

Para-Pak LV-PVA / Ultra 10% Formalin 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI 53ce51f1-140f-4201-b38a-8bf9a05a7ad9 37 fields · synced Jun 1, 2026