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 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 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
Cleared Feb 12, 1998
QUIKSTRIP ONE STEP BARBITURATE TEST
K974712
Syntron Bioresearch, Inc.
Toxicology · 57d
Cleared Oct 02, 1997
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST
K973047
Drial Consultants, Inc.
Toxicology · 48d
Cleared Oct 30, 1996
VERDICT BARBITURATES
K963529
Editek, Inc.
Toxicology · 56d
Cleared Aug 15, 1996
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
K962669
Princeton BioMeditech Corp.
Toxicology · 37d
Cleared Jun 28, 1996
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD
K961010
Princeton BioMeditech Corp.
Toxicology · 107d