LIN · Class II · 21 CFR 866.3175

FDA Product Code LIN: Antisera, Conjugated Fluorescent, Cytomegalovirus

Leading manufacturers include Baxter Healthcare 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
1–17 of 17
Cleared Jun 13, 2008
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
K081164
Diagnostic Hybrids, Inc.
Microbiology · 50d
Cleared Sep 15, 1999
NUCLISENS CMV PP67
K983762
Organon Teknika Corp.
Microbiology · 324d
Cleared Mar 25, 1994
PATHODX CYTOMEGALOVIRUS
K934798
Diagnostic Products Corp.
Microbiology · 169d
Cleared Aug 11, 1992
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
K921616
Incstar Corp.
Microbiology · 127d
Cleared Dec 04, 1991
CMV-EA MAB TEST
K912592
Gull Laboratories, Inc.
Microbiology · 177d
Cleared Apr 17, 1991
OPUS CMV TEST SYSTEM
K905257
Pb Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Oct 16, 1990
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
K904036
Baxter Healthcare Corp
Microbiology · 41d
Cleared Aug 10, 1989
CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
K894002
Baxter Healthcare Corp
Microbiology · 66d
Cleared Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
K893467
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893468
Immuno Concepts, Inc.
Microbiology · 72d
Cleared May 13, 1986
CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
K860279
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 119d
Cleared May 03, 1982
CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
K820895
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 34d

About Product Code LIN - Regulatory Context