FDA Product Code LIN: Antisera, Conjugated Fluorescent, Cytomegalovirus
Leading manufacturers include Biotest Diagnostics Corp., Bartels Immunodiagnostic Supplies, Inc. and Immuno Concepts, Inc..
17
Total
17
Cleared
142d
Avg days
1982
Since
FDA 510(k) Cleared Antisera, Conjugated Fluorescent, Cytomegalovirus Devices (Product Code LIN)
17 devices
Cleared
Jun 13, 2008
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
Diagnostic Hybrids, Inc.
Microbiology
50d
Cleared
Sep 15, 1999
NUCLISENS CMV PP67
Organon Teknika Corp.
Microbiology
324d
Cleared
Jul 12, 1999
CMV BRITE TURBO KIT
Biotest Diagnostics Corp.
Microbiology
60d
Cleared
Jun 07, 1996
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
Light Diagnostics
Microbiology
414d
Cleared
Jan 30, 1996
CMV BRITE ANTIGENEMIA TEST KIT
Biotest Diagnostics Corp.
Microbiology
301d
Cleared
Mar 25, 1994
PATHODX CYTOMEGALOVIRUS
Diagnostic Products Corp.
Microbiology
169d
Cleared
Aug 11, 1992
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
Incstar Corp.
Microbiology
127d
Cleared
Dec 04, 1991
CMV-EA MAB TEST
Gull Laboratories, Inc.
Microbiology
177d
Cleared
Apr 17, 1991
OPUS CMV TEST SYSTEM
Pb Diagnostic Systems, Inc.
Microbiology
147d
Cleared
Oct 16, 1990
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
Baxter Healthcare Corp
Microbiology
41d
Cleared
Aug 10, 1989
CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
Baxter Healthcare Corp
Microbiology
66d
Cleared
Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
Immuno Concepts, Inc.
Microbiology
72d
Cleared
Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
Immuno Concepts, Inc.
Microbiology
72d
Cleared
May 13, 1986
CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology
119d
Cleared
May 03, 1982
CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
Bartels Immunodiagnostic Supplies, Inc.
Microbiology
34d