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Para-Pak SVT

FDA UDIEUDAMED

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Para-Pak SVT FDA UDI
Generic Name
Faecal specimen container IVD, transport buffer/medium FDA UDI
Device Name
Para-Pak SVT (Single Vial Transport) is a convenient one-vial system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Stool specimens preserved in Para-Pak SVT can be used for direct examination, concentration, permanent stain and in fecal immunoassays. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI
Model / Reference
9016-01 FDA UDI
Description
Para-Pak SVT (Single Vial Transport) is a convenient one-vial system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Stool specimens preserved in Para-Pak SVT can be used for direct examination, concentration, permanent stain and in fecal immunoassays. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI

Identifiers

Catalog Number
9016-01 FDA UDI
Primary DI / UDI-DI
00840733103407 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

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

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 SVT by Meridian Bioscience, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (2)

  • FDA UDI aad8febf-e8b4-4b0b-b9bc-f29e2152897b 36 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026