Immuno-Mycologics, Inc — FDA Profile

Summary

Number	Class	Product	Date
Z-1389-2025	Class II	Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Con	February 10, 2025
Z-0545-2022	Class II	CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal	January 3, 2022
Z-2301-2020	Class II	Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included F	November 4, 2019
Z-2409-2018	Class II	Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Latera	March 30, 2018
Z-1109-2017	Class II	Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003	December 27, 2016
Z-2040-2016	Class II	Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive c	May 9, 2016

K-Number	Device	Date
K120946	ALPHA CRYPTOCOCCAL ANTIGEN EIA	December 17, 2012
K112422	CRAG LATERAL FLOW ASSAY (LFA)	March 28, 2012
K102286	CRAG LATERAL FLOW ASSAY (CRAG LFA)	July 20, 2011
K101407	ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102	July 19, 2011
K883333	RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT	August 25, 1988
K880029	EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001	February 24, 1988
K843286	EI-CANDIDA ENZYME IMMUNOASSAY EI1001	October 1, 1984
K831918	LA-STAPH IDENTIFICATION SYSTEM	June 8, 1983
K830837	LA-HISTO ANTIBODY SYSTEM #HL 1001	May 5, 1983
K810510	YA-CRYPTO ANTIBODY TUBE AGGLUTINATION	March 20, 1981
K802427	LA-SPORO ANTIBODY SYSTEM	October 31, 1980
K800908	CAPIK-CANDIDA ALBICANS IDENT. KIT.	June 2, 1980
K791383	CANDIDA IMMUNODIFFUSION KIT #CA1001	August 16, 1979
K791384	FUNGAL IMMUNODIFFUSION KIT #ID1001	August 16, 1979
K791394	HISTOPLASMA MYCELIAL #CF10020X	August 16, 1979
K791382	CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION	August 16, 1979
K791390	ANTI-BLASTOMYCES SERUM #CF10027X	August 16, 1979
K791389	COCCIDIOIDES ANTIGEN #CF10023X	August 16, 1979
K791392	ANTI-HISTOPLASMA SERUM #CF10026X	August 16, 1979
K791381	COCCIDIODES (COCCI)	August 16, 1979