LKT · Class I · 21 CFR 866.3480

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
1–23 of 23
Cleared Dec 23, 2008
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
K081928
Diagnostic Hybrids, Inc.
Microbiology · 169d
Cleared Mar 18, 1999
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336
Diagnostic Products Corp.
Microbiology · 176d
Cleared Dec 19, 1994
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317
Diagnostic Products Corp.
Microbiology · 161d
Cleared Dec 09, 1991
RSV-MAB TEST
K912842
Gull Laboratories, Inc.
Microbiology · 166d
Cleared Sep 27, 1991
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
K912838
Baxter Diagnostics, Inc.
Microbiology · 93d
Cleared Sep 23, 1991
BIOMERIEUX RSV DIRECT IF KIT
K912371
Vitek Systems, Inc.
Microbiology · 117d
Cleared Nov 22, 1988
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
K884192
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Aug 30, 1988
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
K882687
Gull Laboratories, Inc.
Microbiology · 61d
Cleared Jul 31, 1987
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
K872082
Medical Diagnostic Technologies, Inc.
Microbiology · 63d
Cleared Aug 21, 1986
CELLMATICS RSV DETECTION SYSTEM
K862321
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Sep 17, 1985
ABBOTT RSV EIA
K852472
Abbott Laboratories
Microbiology · 98d
Cleared Aug 19, 1985
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
K852185
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 91d
Cleared Oct 05, 1984
ORTHO* RSV ANTIGEN ELISA TEST SYS
K842047
Ortho Diagnostic Systems, Inc.
Microbiology · 137d
Cleared Aug 12, 1984
ORTHO RESPIRATORY SYNCYTIAL VIRUS-
K841527
Ortho Diagnostic Systems, Inc.
Microbiology · 122d
Cleared Aug 11, 1983
ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS
K831924
Electro-Nucleonics Laboratories, Inc.
Microbiology · 57d

About Product Code LKT - Regulatory Context