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
May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
Alfa Scientific Designs, Inc.
Toxicology
165d
Cleared
May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
Alfa Scientific Designs, Inc.
Toxicology
165d
Cleared
May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
Syva Co., Dade Behring, Inc.
Toxicology
16d
Cleared
Apr 17, 2000
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
Dade Behring, Inc.
Toxicology
66d
Cleared
Apr 03, 2000
RAPIDONE- BENZODIAZEPINE TEST
American Bio Medica Corp.
Toxicology
234d
Cleared
Jan 27, 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
Syva Co.
Toxicology
64d
Cleared
Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
Roche Diagnostics Corp.
Toxicology
57d
Cleared
Apr 15, 1999
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
Princeton BioMeditech Corp.
Toxicology
20d
Cleared
Feb 11, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
Roche Diagnostic Systems, Inc.
Toxicology
113d
Cleared
Nov 18, 1998
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
Roche Diagnostic Systems, Inc.
Toxicology
69d
Cleared
Nov 12, 1998
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
OraSure Technologies, Inc.
Toxicology
93d
Cleared
Jun 03, 1998
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
Phamatech
Toxicology
21d
Cleared
Apr 29, 1998
ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
Tcpi, Inc.
Toxicology
58d
Cleared
Feb 25, 1998
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST
Drial Consultants, Inc.
Toxicology
180d
Cleared
Feb 24, 1998
QUIKPAC II ONE STEP BENZODIAZEPINE TEST
Drial Consultants, Inc.
Toxicology
173d
Cleared
Dec 11, 1997
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B
Princeton BioMeditech Corp.
Toxicology
35d
Cleared
Dec 10, 1996
CEDIA DAU BENZODIAZEPINE ASSAY
Boehringer Mannheim Corp.
Toxicology
148d
Cleared
Aug 30, 1996
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
Princeton BioMeditech Corp.
Toxicology
52d
Cleared
Jun 12, 1996
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP
Princeton BioMeditech Corp.
Toxicology
65d
Cleared
May 20, 1996
BENZODIAZEPINE SERUM TOX EIA TEST
Diagnostic Reagents, Inc.
Toxicology
89d
Cleared
Nov 27, 1995
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
Microgenics Corp.
Toxicology
55d
Cleared
Oct 05, 1995
VISUALINE II BENZODIAZEPINES
Sun Biomedical Laboratories, Inc.
Toxicology
94d
Cleared
Jun 20, 1995
CEDIA DAU BENZODIAZEPINE ASSAY
Microgenics Corp.
Toxicology
67d
Cleared
May 16, 1995
AXSYM BENZODIAZEPINES
Abbott Laboratories
Toxicology
56d