Product code DIS— Clinical Toxicology
CEDIA DAU BARBITURATE ASSAY
- Classification name
- Enzyme Immunoassay, Barbiturate
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Total cleared
- 100
- First cleared
- Most recent
Market context for product code DIS
FDA has cleared devices under product code DIS between 1979 and 2016, filed by 48 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2016
- 2015
- 2014
- 2011
- 2007
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
Top applicants under product code DIS
Recent clearances under product code DIS
- K161714 — Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K151211 — AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
- K150791 — Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
- K143535 — CR3 Keyless Split Sample Cup Secobarbital- Methadone
- K140665 — GenPrime Snap-Top Split Key Cup
- K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
- K092268 — RANDOX BARITURATES ASSAY
- K110515 — UCP DRUG SCREENING TEST CUPS
- K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X
- K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC
- K062165 — VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS
- K050024 — ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
- K050593 — ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
- K042975 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
- K043211 — ONLINE DAT BARBITURATES PLUS
- K041143 — RANDOX BARBITURATE ASSAY
- K041712 — 'RAPIDTEC 4' TEST
- K033885 — BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
- K033334 — PROFILE -ER
- K032764 — BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
- K023946 — ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
- K014089 — VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
- K012996 — BARBITURATES
- K020136 — VISUALINE BARBITURATES DIPSTRIP TEST
- K012824 — ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
- K012133 — LIVESURE BARBITURATES SCREEN TEST
- K003647 — INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
- K010125 — INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
- K010934 — EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
- K010959 — VERDICT -II BAR; VERDICT -II BZO
- K010561 — VERDICT -II BAR/BZO
- K002331 — PROFILE-ER
- K001976 — STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
- K002337 — BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST
- K000522 — SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
- K000459 — URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
- K992451 — RAPIDONE- BARBITURATE TEST
- K990280 — BIONIKE AQ BARBITURATE TEST
- K991440 — ROCHE COBAS INTEGRA SERUM BARBITURATES
- K983698 — MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
- K991018 — ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
- K991076 — ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP
- K991082 — ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO
- K991084 — ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
- K982745 — AUTO-LYTE BARBITURATES EIA
- K982152 — QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152
- K982551 — ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN
- K980349 — QUICKPAC II ONE STEP BARBITURATE TEST
- K974712 — QUIKSTRIP ONE STEP BARBITURATE TEST
- K973047 — ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST
- K963529 — VERDICT BARBITURATES
- K962669 — ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
- K961010 — ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD
- K960664 — BARBITURATE SERUM TOX EIA ASSAY
- K955928 — BARBITURATE EIA ESSAY (MODIFICATION)
- K953021 — ACS PHENOBARBITAL
- K951253 — AXSYM BARBITURATES II U
- K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
- K935116 — EMIT IIC BARBITURATE ASSAY
- K944075 — CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST
- K945344 — CEDIA DAU BARBITURATE ASSAY
- K942436 — CEDIA DAU BARBITURATE ASSAY
- K942404 — CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION
- K941489 — ACE CLINICAL CHEMISTRY SYSTEM
- K936030 — CEDIA DAU BARBITURATE ASSAY
- K934376 — STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
- K933480 — MICROLINE SCREEN FOR BARBITURATES
- K931535 — EMIT(R) D.A.U. BARBITURATE ASSAY
- K926068 — EMIT(R) II BARBITURATE ASSAY
- K925491 — BARBITURATE EIA TEST
- K920525 — BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL
- K920417 — IL TEST BARBITURATE, 35289
- K920314 — TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)
- K905057 — EZ-SCREEN:BARBITURATES
- K903825 — DRUG OF ABUSE ANALYSIS SYSTEM
- K902580 — EMIT(R) II BARBITURATE ASSAY
- K896550 — TDX(R) BARBITURATES II ASSAY
- K890690 — ADX TM BARBITURATES
- K892650 — TDX BARBITURATES SERUM
- K890884 — ABUSCREEN FP FOR BARBITURATES
- K882663 — BARBITURATE ENZYME IMMUNOASSAY KIT
- K882611 — EMIT HVA BARBITURATE ASSAY
- K880012 — REVISED LABELING FOR ADX BARBITURATES
- K874702 — REVISED LABELING FOR SYVA BARBITURATE ASSAYS
- K874483 — REVISED LABELING FOR TDX BARBITURATES
- K874210 — REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
- K874266 — REVISED LABELING FOR BARBITURATE TEST KIT
- K873623 — ACA URINE BARBITURATES SCREEN METHOD
- K873754 — LABELING CHANGE BARBITURATES IN URINE
- K864993 — QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
- K870936 — COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5
- K870378 — ABUSCREEN (R) EIA BARBITURATE
- K842675 — EMIT D.A.U. BARBITURATE ASSAY
- K843418 — EMIT 700 BARBITURATE ASSAY
- K842783 — ACA BARBITURATES SCREEN ANALY TEST PACK
- K840194 — EMIT ST SERUM BARBITURATE ASSAY
- K833577 — MODIF. OF EMIT URINE BARBITURATE
- K810602 — EMIT-ST SERUM BARBITURATE ASSAY
- K802617 — EMIT-STM BARBITURATE ASSAY
- K792114 — EMIT-BARBITURATE ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.