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Coccidioides "TP" Antigen for Fungal Immunodiffusion

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Coccidioides "TP" Antigen for Fungal Immunodiffusion FDA UDI
Generic Name
Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion FDA UDI
Device Name
Coccidioides immitis antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Coccidioides immitis (C. imm.). Reagents are available for detection of either “TP” (early) or “F” (late) antibodies. These reagents are optimized for use in the Ouchterlony double diffusion. FDA UDI
Model / Reference
103001 FDA UDI
Description
Coccidioides immitis antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Coccidioides immitis (C. imm.). Reagents are available for detection of either “TP” (early) or “F” (late) antibodies. These reagents are optimized for use in the Ouchterlony double diffusion. FDA UDI

Identifiers

Catalog Number
103001 FDA UDI
Primary DI / UDI-DI
00840733101076 FDA UDI
510(k) Number
K792682 FDA UDI
FDA Product Code
GMI FDA UDI
GMDN Term
Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3135 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: Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion

Coccidioides "TP" Antigen for Fungal Immunodiffusion by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion.

Cleared under the same submission

K792682 also covers:

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 9a9ecf08-f2b8-4698-9945-f4b7587d231f 37 fields · synced May 30, 2026