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 Ortho Diagnostic Systems, Inc..

67
Total
67
Cleared
145d
Avg days
1982
Since
67 devices
25–48 of 67
Cleared Jul 27, 1990
QUIDEL CHLAMYDIA TEST
K901660
Quidel Corp.
Microbiology · 108d
Cleared Jul 26, 1990
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
K902253
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 66d
Cleared Jun 20, 1990
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934
Eastman Kodak Company
Microbiology · 51d
Cleared May 03, 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543
Abbott Laboratories
Microbiology · 87d
Cleared Mar 08, 1990
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
K900402
Eastman Kodak Company
Microbiology · 38d
Cleared Jan 29, 1990
CLEARVIEW CHLAMYDIA
K895280
Unipath , Ltd.
Microbiology · 158d
Cleared Jan 02, 1990
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
K895505
Eastman Kodak Company
Microbiology · 113d
Cleared Oct 30, 1989
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K895122
Ciba Corning Diagnostics Corp.
Microbiology · 76d
Cleared Jul 25, 1989
ABBOTT TESTPACK CHLAMYDIA
K893676
Abbott Laboratories
Microbiology · 70d
Cleared Jun 02, 1989
CHLAMYDIAZYME BLOCKING REAGENT
K892371
Abbott Laboratories
Microbiology · 57d
Cleared Mar 22, 1989
MICROTRAK CHLAMYDIA EIA
K890196
Syva Co.
Microbiology · 63d
Cleared Dec 16, 1988
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006
Abbott Laboratories
Microbiology · 14d
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 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 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 Aug 26, 1986
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
K862638
Isolab, Inc.
Microbiology · 47d
Cleared Oct 05, 1983
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC
K831962
Abbott Laboratories
Chemistry · 110d