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Immy

FDA UDI

Class II (US FDA UDI)

by Immuno-Mycologics, Inc.

Identity

Trade Name
IMMY FDA UDI
Generic Name
Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinical FDA UDI
Device Name
Latex-Cryptococcus Antigen Detection System FDA UDI
Model / Reference
CR1003 FDA UDI
Description
Latex-Cryptococcus Antigen Detection System FDA UDI

Identifiers

Primary DI / UDI-DI
00816387020827 FDA UDI
510(k) Number
K791382 FDA UDI
FDA Product Code
GMD FDA UDI
GMDN Term
Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3165 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

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: Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinical

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

Similar devices

Also classified as Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinical.

Cleared under the same submission

K791382 also covers:

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 cfcfe064-5821-4f5c-b4a2-90f85ccffd6c 35 fields · synced May 30, 2026