Product Code: KFH FDA class 2 21 CFR 866.3060

Antiserum, Positive Control, Blastomyces Dermatitidis

Microbiology

Antiserum, Positive Control, Blastomyces Dermatitidis is a laboratory reagent used as a positive control in serological tests for diagnosing blastomycosis, a fungal infection caused by Blastomyces dermatitidis, helping to confirm the reliability of immunodiffusion and complement fixation assays. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KFH, regulated under 21 CFR 866.3060, within the Microbiology medical specialty.

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Basic Information

Product Code: KFH
Device Class: FDA class 2
Regulation Number: 866.3060
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K880029	EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001	Feb 24, 1988	Substantially Equivalent	Immuno-Mycologics, Inc.
K792685	BLASTOMYCES DERMATITIDIS, ANTISERUM	Jan 17, 1980	Substantially Equivalent	Meridian Diagnostics, Inc.
K792681	BLASTOMYCES DERMATITIDIS POS/CONTROL	Jan 17, 1980	Substantially Equivalent	Meridian Diagnostics, Inc.
K760833	ANTI-BLASTOMYCES CONTROL SERUM (YEAST)	Nov 01, 1976	Substantially Equivalent	I M, Inc.