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Immy

FDA UDI

Class I (US FDA UDI)

by Immuno-Mycologics, Inc.

Identity

Trade Name
IMMY FDA UDI
Generic Name
Histoplasma capsulatum total antibody IVD, reagent FDA UDI
Device Name
1000 EIA Unit Histoplasma Antigens FDA UDI
Model / Reference
HAG000 FDA UDI
Description
1000 EIA Unit Histoplasma Antigens FDA UDI

Identifiers

Primary DI / UDI-DI
00816387020414 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Histoplasma capsulatum total antibody IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 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: Histoplasma capsulatum total antibody IVD, reagent

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

Similar devices

Also classified as Histoplasma capsulatum 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 e3a7a15e-cf17-459b-b863-085fcea99bbd 34 fields · synced May 30, 2026