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Immy

FDA UDI

Class II (US FDA UDI)

by Immuno-Mycologics, Inc.

Identity

Trade Name
IMMY FDA UDI
Generic Name
Blastomyces dermatitidis total antibody IVD, reagent FDA UDI
Device Name
Blastomyces CF Antigen Dilute FDA UDI
Model / Reference
B10150-M FDA UDI
Description
Blastomyces CF Antigen Dilute FDA UDI

Identifiers

Primary DI / UDI-DI
00816387020131 FDA UDI
FDA Product Code
LSH FDA UDI
GMDN Term
Blastomyces dermatitidis total antibody IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3060 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: Blastomyces dermatitidis 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 Blastomyces dermatitidis 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 b8666d7b-a3fa-4862-95d8-97b10b70caa6 34 fields · synced May 30, 2026