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Panels › Microbiology › Product code GMD · Class 2

Antisera, Latex Agglutination, Cryptococcus Neoformans

Regulation 866.3165

0510(k)s in 12 months (10 all time)

0recalls in 12 months (3 all time)

3recalls that name a 510(k)

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Top companies in GMD

Company	510(k)s	Recalls
Immuno-Mycologics, Inc.	4	3
Meridian Diagnostics, Inc.	2	0
Alexon Biomedical, Inc.	1	0
American Scientific Products	1	0
I M, Inc.	1	0
Trinity Laboratories, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Jan 3, 2022	Immuno-Mycologics, Inc CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919 Terminated	GMD	K112422
Mar 30, 2018	Immuno-Mycologics, Inc Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detectio Terminated	GMD	K112422
Jan 27, 2017	Immuno-Mycologics, Inc Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 Terminated	GMD	K112422

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