LJC · Class I · 21 CFR 866.3120

FDA Product Code LJC: Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

Leading manufacturers include Abbott Laboratories, Syva Co. and Kallestad Diag, A Div. of Erbamont, Inc..

67
Total
67
Cleared
145d
Avg days
1982
Since
67 devices
49–67 of 67
Cleared Nov 30, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
K884517
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 34d
Cleared Nov 10, 1988
KODAK SURECELL CHLAMYDIA TEST KIT
K882923
Eastman Kodak Company
Microbiology · 120d
Cleared Oct 25, 1988
FDL ELISA FOR CHLAMYDIA
K883266
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 83d
Cleared Aug 29, 1988
PHARMACIA CHLAMYDIA EIA
K882676
Pharmacia, Inc.
Microbiology · 62d
Cleared Jul 25, 1988
ABBOTT TESTPACK CHLAMYDIA
K880783
Abbott Laboratories
Microbiology · 150d
Cleared Jul 14, 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535
Abbott Laboratories
Microbiology · 23d
Cleared May 23, 1988
CHLAMYDIAZYME(TM)
K880469
Abbott Laboratories
Microbiology · 110d
Cleared Apr 12, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
K880824
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 42d
Cleared Sep 11, 1987
CHLAMYSET ANTIBODY EIA
K864457
Orion Corp.
Microbiology · 303d
Cleared Aug 19, 1987
VIVID CHLAMYDIA(TM)
K872148
Seragen Diagnostics, Inc.
Microbiology · 76d
Cleared Jun 15, 1987
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
K872056
Boots-Celltech Diagnostics, Inc.
Microbiology · 18d
Cleared Apr 29, 1987
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842
Abbott Laboratories
Microbiology · 140d
Cleared Nov 05, 1986
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
K863490
Ortho Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Oct 17, 1986
CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)
K862948
Intercare Diagnostics, Inc.
Microbiology · 73d
Cleared Aug 26, 1986
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
K862638
Isolab, Inc.
Microbiology · 47d
Cleared Aug 19, 1986
MODIFIED IDEIA CHLAMYDIA TEST
K861966
Boots-Celltech Diagnostics, Inc.
Microbiology · 91d
Cleared Sep 12, 1984
APPLELISA CHLAMYDIA TRACHOMATIS ANTI
K843120
Apple Diagnostic Products
Microbiology · 35d
Cleared Oct 05, 1983
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC
K831962
Abbott Laboratories
Chemistry · 110d
Cleared Aug 03, 1982
CHLAMYDELISA TEST KIT
K821967
M.A. Bioproducts
Microbiology · 32d