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
Cleared
Feb 18, 1992
EMIT D.A.U BENZODIAZEPINE ASSAY
Syva Co.
Toxicology
71d
Cleared
Jan 27, 1992
IL TEST(TM) BENZODIAZEPINE
Instrumentation Laboratory CO
Chemistry
94d
Cleared
Nov 01, 1991
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
Roche Diagnostic Systems, Inc.
Toxicology
23d
Cleared
Apr 05, 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
Roche Diagnostic Systems, Inc.
Toxicology
52d
Cleared
Feb 22, 1991
EMIT II BENZODIAZEPINE ASSAY
Syva Co.
Toxicology
24d
Cleared
Feb 23, 1990
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
Bio-Rad
Toxicology
85d
Cleared
Aug 25, 1989
ADX TM BENZODIAZEPINES
Abbott Laboratories
Toxicology
192d
Cleared
Mar 31, 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
Roche Diagnostic Systems, Inc.
Toxicology
9d
Cleared
Jan 24, 1989
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
Diagnostic Products Corp.
Toxicology
21d
Cleared
Nov 29, 1988
TDX BENZODIAZEPINES SERUM
Abbott Laboratories
Toxicology
90d
Cleared
Sep 09, 1988
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5
Diagnostic Products Corp.
Toxicology
28d
Cleared
Feb 11, 1988
REVISIED LABELING FOR ADX BENZODIAZEPINES
Abbott Laboratories
Toxicology
38d
Cleared
Nov 23, 1987
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
Syva Co.
Toxicology
28d
Cleared
Nov 23, 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
Abbott Laboratories
Toxicology
24d
Cleared
Nov 13, 1987
REVISED LABELING FOR BENZODIAZEPINE TEST KIT
Roche Diagnostic Systems, Inc.
Toxicology
24d
Cleared
Oct 02, 1987
ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
31d
Cleared
Mar 24, 1987
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
Roche Diagnostic Systems, Inc.
Toxicology
13d
Cleared
Jul 11, 1986
TDX BENZODIAZEPINES
Abbott Laboratories
Toxicology
29d
Cleared
May 10, 1985
EMIT 700 BENZODIAZEPINE ASSAY
Syva Co.
Toxicology
24d
Cleared
Sep 26, 1984
EMIT D.A.U. BENZODIAZEPINE ASSAY
Syva Co.
Toxicology
70d
Cleared
Aug 15, 1984
ACA BENZODIAZEPINES SCREEN TEST PK
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
58d
Cleared
Mar 19, 1984
EMIT ST SERUM BENZODIAZEPINE ASSAY
Syva Co.
Toxicology
59d
Cleared
Jan 26, 1984
MODIF. OF EMIT URINE BENZODIAZEPINE
Syva Co.
Toxicology
106d
Cleared
Mar 06, 1981
EMIT-ST SERUM BENZODIAZEPINE ASSAY
Syva Co.
Toxicology
11d