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Immy

FDA UDI

Class II (US FDA UDI)

by Immuno-Mycologics, Inc.

Identity

Trade Name
IMMY FDA UDI
Generic Name
Coccidioides immitis total antibody IVD, reagent FDA UDI
Device Name
Coccidioides CF Antigen Dilute FDA UDI
Model / Reference
C10150-M FDA UDI
Description
Coccidioides CF Antigen Dilute FDA UDI

Identifiers

Primary DI / UDI-DI
00816387020186 FDA UDI
FDA Product Code
GMI FDA UDI
GMDN Term
Coccidioides immitis total antibody IVD, reagent 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

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: Coccidioides immitis total antibody IVD, reagent

Immy by Immuno-Mycologics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coccidioides immitis total antibody IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immuno-Mycologics, Inc.

Sources (1)

  • FDA UDI ab2cc5f5-1a50-485c-a5a7-02bf73832036 34 fields · synced May 30, 2026