FDA 510(k) Applications for Medical Device Product Code "LFZ"
(Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)

FDA 510(k) Number Applicant Device Name Decision Date
K954301 ABBOTT LABORATORIES ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) 03/24/1997
K953943 ABBOTT LABORATORIES AXSYM CMV IGG ANTIBODY ASSAY 09/20/1996
K900474 ABBOTT LABORATORIES IMX CMV IGG ANTIBODY ASSAY 07/27/1990
K900473 ABBOTT LABORATORIES IMX CMV IGM ANTIBODY ASSAY 07/27/1990
K832221 ABBOTT LABORATORIES YBBOTT CMV TOTAL AB EIA 10/27/1983
K922582 BAXTER DIAGNOSTICS, INC. BARTELS CYTOMEGALOVIRUS IGG EIA 04/08/1993
K852478 BEHRING DIAGNOSTICS, INC. ENZYGNOST + ANTI-CMV IGG TEST 09/16/1985
K901485 BEHRING DIAGNOSTICS, INC. ENZYGNOST ANTI-CMV/IGG + IGM 05/20/1991
K913910 BEHRING DIAGNOSTICS, INC. ENZYGNOST(R) ANTI-CMV IGG 04/28/1992
K913693 BEHRING DIAGNOSTICS, INC. ENZYGNOST(R) ANTI-CMV/IGM 02/27/1992
K963084 BEHRING DIAGNOSTICS, INC. OPUS CMV TEST SYSTEM-MODIFICATION 10/09/1996
K823123 CORDIS CORP. CORDIA CMV 12/28/1982
K880433 DE FERRIS LABORATORIES, INC. CYTOMEGALOVIRUS IGG EIA KIT 03/27/1989
K993952 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 12/16/1999
K950672 DIAGNOSTIC PRODUCTS CORP. IMMULITE CMV IGG 06/17/1996
K981163 DIAMEDIX CORP. DIAMEDIX IS-CMV IGG TEST SYSTEM 09/21/1998
K162969 DiaSorin Inc. LIAISON« CMV IgG and LIAISON« CMV IgG Serum Control Set 01/06/2017
K040290 DIASORIN S.P.A. DIASORIN LIAISON CMV IGM/IGG 06/01/2005
K982027 DIASORIN, INC. MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY 11/25/1998
K884842 DIFCO LABORATORIES, INC. CMV-CUBE(TM) 04/11/1989
K884248 DISEASE DETECTION INTERNATIONAL, INC. MODIFIED DDI SEROCARD CMV IGG TEST KIT 04/10/1989
K875361 DISEASE DETECTION INTERNATIONAL, INC. SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT 05/13/1988
K900796 GULL LABORATORIES, INC. CMV IGG ELISA TEST 05/02/1990
K915892 GULL LABORATORIES, INC. CMV IGG ELISA TEST 02/14/1992
K903807 GULL LABORATORIES, INC. CMV IGM ELISA TEST 12/17/1990
K893230 GULL LABORATORIES, INC. DETECTADOT TM SYSTEM 2000 CMV IGM TEST 12/18/1989
K944438 HEMAGEN DIAGNOSTICS, INC. HEMAGEN CMV IGG KIT 02/20/1997
K955361 INCSTAR CORP. INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY 07/22/1996
K955360 INCSTAR CORP. INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY 07/22/1996
K960434 INCSTAR CORP. INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 10/17/1996
K971335 INOVA DIAGNOSTICS, INC. QUANTA LITE CMV IGG ELISA 12/01/1997
K831343 LITTON BIONETICS CMV RQ BIO-ENZABEAD KIT 08/08/1983
K830615 M.A. BIOPRODUCTS CYTOMEGELISA STAT 05/09/1983
K915479 MERCIA DIAGNOSTICS LTD. CAPTIA CMV-TA 05/04/1992
K896194 MERCIA DIAGNOSTICS LTD. CAPTIA(R) CMV-G 03/06/1990
K896295 MERCIA DIAGNOSTICS LTD. CAPTIA(R) CMV-M 03/06/1990
K890610 ORGANON TEKNIKA CORP. VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM 06/23/1989
K891393 ORGENICS LTD. ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT 06/23/1989
K905078 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO CMV-G ANTIBODY ELISA TEST 12/17/1990
K905077 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO CMV-M ANTIBODY ELISA TEST 12/17/1990
K933389 PB DIAGNOSTIC SYSTEMS, INC. OPUS CMV-G 06/28/1994
K921011 PHARMACIA DIAGNOSTICS, INC. PHARMACIA CMV IGM ELISA 07/27/1992
K954191 QUEST INTL., INC. SERAQUEST CMV IGG 02/23/1996
K982485 QUEST INTL., INC. SERAQUEST CMV IGM 01/13/1999
K163569 Roche Diagnostics Elecsys CMV IgM 03/17/2017
K131605 Roche Diagnostics ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY 02/28/2014
K142133 Roche Diagnostics ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM 10/24/2014
K181213 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control 07/30/2018
K883399 UNITED BIOTECH, INC. UBI MAGIWEL CMV IGG QUANTITATIVE 03/27/1989
K904456 VIROTECH, INC. CYTOMEGALOVIRUS (CMV) ELISA 04/03/1991
K920661 VITEK SYSTEMS, INC. VIDAS CMV IGG ASSAY 02/12/1993
K924096 ZEUS SCIENTIFIC, INC. CMV ELISA TEST SYSTEM 04/02/1993
K891081 ZEUS SCIENTIFIC, INC. CMV ELISA TEST SYSTEM 06/02/1989
K896355 ZEUS SCIENTIFIC, INC. CMV IGM ELISA TEST SYSTEM 02/27/1990
K984139 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE 01/11/1999
K983803 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE 12/14/1998


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