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Immy

FDA UDI

Class II (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
Histoplasma Mycelial CF Antigen Dilute FDA UDI
Model / Reference
H10150-M FDA UDI
Description
Histoplasma Mycelial CF Antigen Dilute FDA UDI

Identifiers

Primary DI / UDI-DI
00816387020346 FDA UDI
510(k) Number
K791394 FDA UDI
FDA Product Code
GMJ FDA UDI
GMDN Term
Histoplasma capsulatum total antibody IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3320 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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Histoplasma capsulatum total antibody IVD, reagent.

Cleared under the same submission

K791394 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 2a40f7ef-70c0-4322-950b-fdc3f35472fc 35 fields · synced Jun 1, 2026