JXM · Class II · 21 CFR 862.3170

FDA Product Code JXM: Enzyme Immunoassay, Benzodiazepine

Benzodiazepine detection is essential in forensic toxicology, emergency medicine, and addiction treatment monitoring. FDA product code JXM covers enzyme immunoassay systems for benzodiazepine detection.

These tests use antibody-based technology to screen for benzodiazepines — including diazepam, lorazepam, and clonazepam — in urine and other biological specimens. They are widely used as initial screening tools before confirmatory chromatographic testing.

JXM devices are Class II medical devices, regulated under 21 CFR 862.3170 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Syva Co., Abbott Laboratories and Roche Diagnostic Systems, Inc..

90
Total
90
Cleared
87d
Avg days
1979
Since
90 devices
49–72 of 90
Cleared May 16, 1995
AXSYM CANNABINOIDS
K951288
Abbott Laboratories
Toxicology · 56d
Cleared Mar 21, 1995
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
K950427
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 47d
Cleared Nov 21, 1994
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS
K944076
Beckman Instruments, Inc.
Toxicology · 139d
Cleared Aug 01, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K942795
Microgenics Corp.
Toxicology · 54d
Cleared May 27, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K940159
Microgenics Corp.
Toxicology · 135d
Cleared Nov 22, 1993
STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA
K934869
Solarcare Technologies Corp,Inc.
Toxicology · 41d
Cleared Aug 05, 1993
BENZODIAZEPINE ENZYME IMMUNOASSAY
K930529
Diagnostic Reagents, Inc.
Toxicology · 184d
Cleared May 11, 1993
EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
K931536
Syva Co.
Toxicology · 43d
Cleared Jan 12, 1993
EMIT(R) II BENZODIAZEPINE ASSAY
K926067
Syva Co.
Toxicology · 42d
Cleared Feb 18, 1992
EMIT D.A.U BENZODIAZEPINE ASSAY
K915501
Syva Co.
Toxicology · 71d
Cleared Jan 27, 1992
IL TEST(TM) BENZODIAZEPINE
K914815
Instrumentation Laboratory CO
Chemistry · 94d
Cleared Nov 01, 1991
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
K914509
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Apr 05, 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
K910590
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Feb 22, 1991
EMIT II BENZODIAZEPINE ASSAY
K910376
Syva Co.
Toxicology · 24d
Cleared Mar 23, 1990
MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K896780
Immunotech Corp.
Toxicology · 109d
Cleared Feb 23, 1990
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
K896744
Bio-Rad
Toxicology · 85d
Cleared Aug 25, 1989
ADX TM BENZODIAZEPINES
K890691
Abbott Laboratories
Toxicology · 192d
Cleared Mar 31, 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
K891697
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Jan 24, 1989
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
K890001
Diagnostic Products Corp.
Toxicology · 21d
Cleared Nov 29, 1988
TDX BENZODIAZEPINES SERUM
K883730
Abbott Laboratories
Toxicology · 90d
Cleared Sep 09, 1988
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5
K883459
Diagnostic Products Corp.
Toxicology · 28d
Cleared Feb 11, 1988
REVISIED LABELING FOR ADX BENZODIAZEPINES
K880014
Abbott Laboratories
Toxicology · 38d
Cleared Nov 23, 1987
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
K874376
Syva Co.
Toxicology · 28d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
K874489
Abbott Laboratories
Toxicology · 24d