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Hemo-De

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Hemo-De FDA UDI
Generic Name
Faecal parasite isolation kit IVD FDA UDI
Device Name
Clearing agent for parasitology, Use as a xylene replacement in Trichrome Stain procedure, Ethyl acetate replacement in concentration procedures, Bulk reagent used in EcoStain kit. FDA UDI
Model / Reference
801300 FDA UDI
Description
Clearing agent for parasitology, Use as a xylene replacement in Trichrome Stain procedure, Ethyl acetate replacement in concentration procedures, Bulk reagent used in EcoStain kit. FDA UDI

Identifiers

Catalog Number
801300 FDA UDI
Primary DI / UDI-DI
00840733102585 FDA UDI
FDA Product Code
HYW FDA UDI
GMDN Term
Faecal parasite isolation kit IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1850 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 parasite isolation kit IVD

Hemo-De 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 9c85871e-33fd-42a4-8dbf-3a6b6a3908c0 36 fields · synced May 30, 2026