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Fungal Immunodiffusion Plates - 1 Series

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Fungal Immunodiffusion Plates - 1 Series FDA UDI
Generic Name
Multiple fungi exoantigen IVD, kit, precipitation/immunodiffusion FDA UDI
Device Name
For the detection of circulating antibody to common systemic pathogens. FDA UDI
Model / Reference
101012 FDA UDI
Description
For the detection of circulating antibody to common systemic pathogens. FDA UDI

Identifiers

Catalog Number
101012 FDA UDI
Primary DI / UDI-DI
00840733101403 FDA UDI
FDA Product Code
JZQ FDA UDI
GMDN Term
Multiple fungi exoantigen IVD, kit, precipitation/immunodiffusion FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.4800 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

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: Multiple fungi exoantigen IVD, kit, precipitation/immunodiffusion

Fungal Immunodiffusion Plates - 1 Series by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple fungi exoantigen IVD, kit, precipitation/immunodiffusion.

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 f64c9231-71ce-4c23-b687-c35c9bc54e8c 34 fields · synced May 31, 2026