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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
LA-Histoplasma Antibody System FDA UDI
Model / Reference
HL1001 FDA UDI
Description
LA-Histoplasma Antibody System FDA UDI

Identifiers

Primary DI / UDI-DI
00816387020841 FDA UDI
510(k) Number
K830837 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.

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 ed53253c-18dd-42b2-b057-29b1e0c9273e 35 fields · synced May 31, 2026