FDA Product Code LKQ: Antibody Igm,if, Cytomegalovirus Virus
Leading manufacturers include Whittaker Bioproducts, Inc., Immuno Concepts, Inc. and Gull Laboratories, Inc..
18
Total
18
Cleared
147d
Avg days
1983
Since
FDA 510(k) Cleared Antibody Igm,if, Cytomegalovirus Virus Devices (Product Code LKQ)
18 devices
Cleared
May 13, 2010
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
Siemens Healthcare Diagnostics
Microbiology
86d
Cleared
Aug 02, 1994
VIDAS CMV IGM ASSAY
Biomerieux Vitek, Inc.
Microbiology
376d
Cleared
Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGM EIA
Baxter Diagnostics, Inc.
Microbiology
316d
Cleared
Mar 04, 1992
ELISA CMV IGM
Sclavo, Inc.
Microbiology
133d
Cleared
Apr 26, 1990
CMV-IGM IFA TEST SYSTEM
Zeus Scientific, Inc.
Microbiology
69d
Cleared
Jul 25, 1989
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
Immuno Concepts, Inc.
Microbiology
83d
Cleared
Jul 14, 1989
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
Immuno Concepts, Inc.
Microbiology
72d
Cleared
May 13, 1988
ABBOTT CMV-M EIA KIT
Abbott Laboratories
Microbiology
296d
Cleared
Jan 11, 1988
IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
Clinical Sciences, Inc.
Microbiology
168d
Cleared
Aug 07, 1987
CMV IGM MICROASSAY
Diamedix Corp.
Microbiology
88d
Cleared
Apr 14, 1987
FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES
Whittaker Bioproducts, Inc.
Microbiology
197d
Cleared
Jul 21, 1986
ENZYGNOST ANTI-CMV IGM TEST
Behring Diagnostics, Inc.
Microbiology
102d
Cleared
Apr 21, 1986
CORDIA CMV-M
Cordis Corp.
Microbiology
214d
Cleared
Feb 04, 1986
CYTOMEGELISA M TEST KIT
Whittaker Bioproducts, Inc.
Microbiology
62d
Cleared
Oct 27, 1983
CMV IGM TEST
Gull Laboratories, Inc.
Immunology
153d