Antisera, Latex Agglutination, Cryptococcus Neoformans

FDA product code GMD · Class II (moderate risk) · 21 CFR 866.3165 · Microbiology

10510(k) clearances
0PMA approvals
3recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K112422Crag Lateral Flow Assay (Lfa)GMD · Traditional Immuno-Mycologics, Inc.03/28/2012SE
K102286Crag Lateral Flow Assay (Crag Lfa)GMD · Traditional Immuno-Mycologics, Inc.07/20/2011SE
K930418Crypto-Lex SystemGMD · Traditional Trinity Laboratories, Inc.02/17/1994SE
K933997Prospect Entamoeba Histolytica Microplate AssayGMD · Traditional Alexon Biomedical, Inc.11/22/1993SE
K894845(Calas(Tm)) W/Add'L Reagent Calas(Tm) PronaseGMD · Traditional Meridian Diagnostics, Inc.09/08/1989SE
K812188Cryptococcal Antigen Latex AgglutiGMD · Traditional American Scientific Products08/31/1981SE
K810510Ya-Crypto Antibody Tube AgglutinationGMD · Traditional Immuno-Mycologics, Inc.03/20/1981SE
K792693Cryptococcus Neoformans Antiserum, LatexGMD · Traditional Meridian Diagnostics, Inc.01/21/1980SE
K791382Cryptococcal Antigen Latex AgglutinationGMD · Traditional Immuno-Mycologics, Inc.08/16/1979SE
K780526Cryptococcal Antigen Latex Agg. SystemGMD · Traditional I M, Inc.04/28/1978SE

Recalls

RecallProductFirmInitiated
Z-0545-2022 Class IICRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of…The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to… Immuno-Mycologics, Inc01/03/2022Terminated
Z-2409-2018 Class IICryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The…Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results Immuno-Mycologics, Inc03/30/2018Terminated
Z-1109-2017 Class IICryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003The affected products have approximately a 91% specificity while the non-affected lots have approximately a… Immuno-Mycologics, Inc12/27/2016Terminated