LFZ · Class II · 21 CFR 866.3175

FDA Product Code LFZ: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Leading manufacturers include Abbott Laboratories, Behring Diagnostics, Inc. and Zeus Scientific, Inc..

58
Total
58
Cleared
198d
Avg days
1982
Since
58 devices
25–48 of 58
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGG EIA
K922582
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Apr 02, 1993
CMV ELISA TEST SYSTEM
K924096
Zeus Scientific, Inc.
Microbiology · 232d
Cleared Feb 12, 1993
VIDAS CMV IGG ASSAY
K920661
Vitek Systems, Inc.
Microbiology · 365d
Cleared May 04, 1992
CAPTIA CMV-TA
K915479
Mercia Diagnostics , Ltd.
Microbiology · 150d
Cleared Apr 28, 1992
ENZYGNOST(R) ANTI-CMV IGG
K913910
Behring Diagnostics, Inc.
Microbiology · 242d
Cleared Feb 27, 1992
ENZYGNOST(R) ANTI-CMV/IGM
K913693
Behring Diagnostics, Inc.
Microbiology · 192d
Cleared Feb 14, 1992
CMV IGG ELISA TEST
K915892
Gull Laboratories, Inc.
Microbiology · 52d
Cleared May 20, 1991
ENZYGNOST ANTI-CMV/IGG + IGM
K901485
Behring Diagnostics, Inc.
Microbiology · 417d
Cleared Dec 17, 1990
CMV IGM ELISA TEST
K903807
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Dec 17, 1990
ORTHO CMV-M ANTIBODY ELISA TEST
K905077
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Dec 17, 1990
ORTHO CMV-G ANTIBODY ELISA TEST
K905078
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Jul 27, 1990
IMX CMV IGM ANTIBODY ASSAY
K900473
Abbott Laboratories
Microbiology · 176d
Cleared Jul 27, 1990
IMX CMV IGG ANTIBODY ASSAY
K900474
Abbott Laboratories
Microbiology · 176d
Cleared May 02, 1990
CMV IGG ELISA TEST
K900796
Gull Laboratories, Inc.
Microbiology · 71d
Cleared Mar 06, 1990
CAPTIA(R) CMV-G
K896194
Mercia Diagnostics , Ltd.
Microbiology · 132d
Cleared Mar 06, 1990
CAPTIA(R) CMV-M
K896295
Mercia Diagnostics , Ltd.
Microbiology · 126d
Cleared Feb 27, 1990
CMV IGM ELISA TEST SYSTEM
K896355
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Dec 18, 1989
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
K893230
Gull Laboratories, Inc.
Microbiology · 234d
Cleared Jun 23, 1989
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
K890610
Organon Teknika Corp.
Microbiology · 136d
Cleared Jun 02, 1989
CMV ELISA TEST SYSTEM
K891081
Zeus Scientific, Inc.
Microbiology · 93d
Cleared Apr 11, 1989
CMV-CUBE(TM)
K884842
Difco Laboratories, Inc.
Microbiology · 141d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD CMV IGG TEST KIT
K884248
Disease Detection International, Inc.
Microbiology · 181d
Cleared Mar 27, 1989
UBI MAGIWEL CMV IGG QUANTITATIVE
K883399
United Biotech, Inc.
Microbiology · 228d
Cleared May 13, 1988
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
K875361
Disease Detection International, Inc.
Microbiology · 134d