FDA Product Code LKT: Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Leading manufacturers include Gull Laboratories, Inc., Baxter Diagnostics, Inc. and Diagnostic Products Corp..
23
Total
23
Cleared
101d
Avg days
1983
Since
FDA 510(k) Cleared Respiratory Syncytial Virus, Antigen, Antibody, Ifa Devices (Product Code LKT)
23 devices
Cleared
Dec 23, 2008
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
Diagnostic Hybrids, Inc.
Microbiology
169d
Cleared
Mar 18, 1999
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
Diagnostic Products Corp.
Microbiology
176d
Cleared
Dec 19, 1994
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
Diagnostic Products Corp.
Microbiology
161d
Cleared
Dec 09, 1991
RSV-MAB TEST
Gull Laboratories, Inc.
Microbiology
166d
Cleared
Sep 27, 1991
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
Baxter Diagnostics, Inc.
Microbiology
93d
Cleared
Sep 23, 1991
BIOMERIEUX RSV DIRECT IF KIT
Vitek Systems, Inc.
Microbiology
117d
Cleared
Nov 22, 1988
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
Baxter Diagnostics, Inc.
Microbiology
47d
Cleared
Aug 30, 1988
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
Gull Laboratories, Inc.
Microbiology
61d
Cleared
Jul 31, 1987
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
Medical Diagnostic Technologies, Inc.
Microbiology
63d
Cleared
Aug 21, 1986
CELLMATICS RSV DETECTION SYSTEM
Difco Laboratories, Inc.
Microbiology
64d
Cleared
Sep 17, 1985
ABBOTT RSV EIA
Abbott Laboratories
Microbiology
98d
Cleared
Aug 19, 1985
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology
91d
Cleared
Oct 05, 1984
ORTHO* RSV ANTIGEN ELISA TEST SYS
Ortho Diagnostic Systems, Inc.
Microbiology
137d
Cleared
Aug 12, 1984
ORTHO RESPIRATORY SYNCYTIAL VIRUS-
Ortho Diagnostic Systems, Inc.
Microbiology
122d
Cleared
Aug 11, 1983
ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS
Electro-Nucleonics Laboratories, Inc.
Microbiology
57d