DIS · Class II · 21 CFR 862.3150

FDA Product Code DIS: Enzyme Immunoassay, Barbiturate

Leading manufacturers include Syva Co., Abbott Laboratories and Princeton BioMeditech Corp..

100
Total
100
Cleared
97d
Avg days
1979
Since
100 devices
25–48 of 100
Cleared Nov 09, 2001
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
K012824
ACON Laboratories, Inc.
Toxicology · 78d
Cleared Jul 20, 2001
LIVESURE BARBITURATES SCREEN TEST
K012133
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared May 29, 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647
Alfa Scientific Designs, Inc.
Toxicology · 183d
Cleared May 29, 2001
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
K010125
Alfa Scientific Designs, Inc.
Toxicology · 183d
Cleared Apr 20, 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
K010934
Syva Co., Dade Behring, Inc.
Toxicology · 23d
Cleared Apr 13, 2001
VERDICT -II BAR
K010959
Medtox Diagnostics, Inc.
Toxicology · 14d
Cleared Apr 05, 2001
VERDICT -II BAR/BZO
K010561
Medtox Diagnostics, Inc.
Toxicology · 38d
Cleared Jan 17, 2001
PROFILE-ER
K002331
Medtox Diagnostics, Inc.
Toxicology · 169d
Cleared Dec 06, 2000
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976
OraSure Technologies, Inc.
Toxicology · 160d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST
K002337
Branan Medical Corporation
Toxicology · 113d
Cleared Apr 18, 2000
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
K000522
Drug Detection Devices, Ltd.
Toxicology · 62d
Cleared Apr 03, 2000
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
K000459
Dade Behring, Inc.
Toxicology · 52d
Cleared Apr 03, 2000
RAPIDONE- BARBITURATE TEST
K992451
American Bio Medica Corp.
Toxicology · 256d
Cleared Jun 28, 1999
BIONIKE AQ BARBITURATE TEST
K990280
Bionike, Inc.
Toxicology · 151d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BARBITURATES
K991440
Roche Diagnostics Corp.
Toxicology · 57d
Cleared May 03, 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698
Roche Diagnostic Systems, Inc.
Toxicology · 194d
Cleared Apr 15, 1999
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
K991018
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP
K991076
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO
K991082
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
K991084
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Nov 18, 1998
AUTO-LYTE BARBITURATES EIA
K982745
OraSure Technologies, Inc.
Toxicology · 104d
Cleared Sep 21, 1998
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152
K982152
Phamatech
Toxicology · 95d
Cleared Aug 18, 1998
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN
K982551
Roche Diagnostic Systems, Inc.
Toxicology · 27d
Cleared Mar 03, 1998
QUICKPAC II ONE STEP BARBITURATE TEST
K980349
Syntron Bioresearch, Inc.
Toxicology · 34d