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
25–48 of 67
Cleared Mar 19, 1991
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
K910668
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Mar 12, 1991
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179
Syva Co.
Microbiology · 113d
Cleared Jan 14, 1991
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K904725
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 89d
Cleared Dec 21, 1990
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
K903132
Ortho Diagnostic Systems, Inc.
Microbiology · 157d
Cleared Oct 02, 1990
QUIDEL CHLAMYDIA POSITIVE CONTROL
K903765
Quidel Corp.
Microbiology · 46d
Cleared Sep 12, 1990
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758
Syva Co.
Microbiology · 23d
Cleared Sep 05, 1990
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
K901972
Novo Nordisk Diagnostics, Ltd.
Microbiology · 127d
Cleared Jul 31, 1990
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K902270
Ciba Corning Diagnostics Corp.
Microbiology · 71d
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 15, 1990
VISUWELL(R) CHLAMYDIA
K900973
Adi Diagnostics, Inc.
Microbiology · 74d
Cleared May 03, 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543
Abbott Laboratories
Microbiology · 87d
Cleared Mar 13, 1990
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
K895468
Orgenics, Ltd.
Microbiology · 183d
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 29, 1990
MODIFIED ELISA FOR CHLAMYDIA
K896032
Fairleigh Dickinson Laboratories, Inc.
Chemistry · 105d
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 Dec 08, 1988
MODIFIED IDEIA CHLAMYDIA TEST
K880799
Boots-Celltech Diagnostics, Inc.
Microbiology · 283d