GMD

Product Code: GMD


Products Classified as GMD

3156Antisera, Latex Agglutination, Cryptococcus NeoformansCryptococcus Neoformans Serological Reagents.

Total Product Life Cycle (TPLC) Devices

3156Antisera, Latex Agglutination, Cryptococcus NeoformansCryptococcus Neoformans Serological Reagents.

Pre-market Notifications for GMD

K112422CRAG LATERAL FLOW ASSAY (LFA)IMMUNO-MYCOLOGICS, INC.
K102286CRAG LATERAL FLOW ASSAY (CRAG LFA)IMMUNO-MYCOLOGICS, INC.
K933997PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAYALEXON BIOMEDICAL, INC.
K930418CRYPTO-LEX SYSTEMTRINITY LABORATORIES, INC.
K894845(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASEMERIDIAN DIAGNOSTICS, INC.
K812188CRYPTOCOCCAL ANTIGEN LATEX AGGLUTIAMERICAN SCIENTIFIC PRODUCTS
K810510YA-CRYPTO ANTIBODY TUBE AGGLUTINATIONIMMUNO-MYCOLOGICS, INC.
K792693CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEXMERIDIAN DIAGNOSTICS, INC.
K791382CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATIONIMMUNO-MYCOLOGICS, INC.

Global Unique Device Identification Database

00816387020919Antisera, Latex Agglutination, Cryptococcus Neoformans
00816387020872Antisera, Latex Agglutination, Cryptococcus Neoformans
00816387020834Antisera, Latex Agglutination, Cryptococcus Neoformans
00816387020827Antisera, Latex Agglutination, Cryptococcus Neoformans
00816387020322Antisera, Latex Agglutination, Cryptococcus Neoformans
00816387020292Antisera, Latex Agglutination, Cryptococcus Neoformans
00848838080913Antisera, Latex Agglutination, Cryptococcus Neoformans
00848838028793Antisera, Latex Agglutination, Cryptococcus Neoformans
00848838026966Antisera, Latex Agglutination, Cryptococcus Neoformans
00840733101090Antisera, Latex Agglutination, Cryptococcus Neoformans
00840733101083Antisera, Latex Agglutination, Cryptococcus Neoformans

Maude Adverse Events

CRAG LFAIMMY2017-04-24
MERIDIAN CALAS CRYPTOCOCCAL ANTIGEN LATEX2008-12-17

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