Product code DIF— Clinical Toxicology
ABUSCREEN ONLINE CONTROLS
- Classification name
- Drug Mixture Control Materials
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Total cleared
- 202
- First cleared
- Most recent
Market context for product code DIF
FDA has cleared devices under product code DIF between 1978 and 2016, filed by 77 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2016
- 2013
- 2012
- 2011
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 1999
- 1998
Top applicants under product code DIF
Recent clearances under product code DIF
1–100 of 202- K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
- K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
- K132174 — MULTICHEM WBT
- K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
- K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
- K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
- K103656 — THERMO SCIENTIFIC MAS R DOA TOTAL
- K093577 — LIQUICHEK OPIATE CONTROL
- K080085 — MAS TOX CONTROL
- K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
- K072721 — LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
- K063398 — ESA LEADCARE II LEAD CONTROL
- K062191 — DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
- K060788 — TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
- K060417 — MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
- K052053 — LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
- K050682 — LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
- K050037 — TRIAGE TOX DRUG SCREEN CONTROLS
- K042865 — LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
- K041666 — DC-ACETA/SAL CONTROLS
- K041561 — LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
- K040758 — MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
- K033924 — LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
- K033366 — LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455
- K033404 — LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
- K032826 — MAS PAR TDM
- K022707 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439
- K021384 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
- K021411 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
- K021414 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
- K021415 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
- K012999 — TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
- K013002 — TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
- K012907 — LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
- K012741 — LIQUICHEK TDM CONTROL
- K012319 — RANDOX HUMAN ASSSAYED DRUG CONTROL
- K992395 — URINE DRUG SCREENING CONTROL
- K990377 — ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
- K983709 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
- K983387 — ONTRAK TESTCUP AND TESTSTIK CONTROLS
- K983127 — OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
- K982649 — VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
- K982217 — AC/AD LINEARITY VERIFIERS
- K982024 — OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
- K981590 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON
- K980871 — LYPHOCHEK WHOLE BLOOD CONTROL
- K980331 — IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
- K972819 — VIGIL TDM CONTROLS
- K971060 — PRECINORM TDM CONTROLS
- K972174 — LYPHOCHEK REMEDI CONTROL
- K971691 — LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
- K971534 — SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
- K971058 — DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
- K970666 — LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
- K964771 — DE-TOX CONTROL 1 AND DE-TOX CONTROL 19
- K965157 — CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
- K964422 — ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
- K962165 — COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
- K961724 — U-DOA CONTROLS
- K960244 — DOCUMENT TDM ULTRA ASSAYED CONTROL
- K955153 — LYPHOCHEK BENZO/TCA CONTROL-SET B
- K955155 — DOCUMENT TDM ULTRA UNASSAYED CONTROL
- K954799 — ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
- K954291 — OPUS TDM CONTROLS
- K954322 — TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
- K953739 — ABUSCREEN ONLINE CONTROLS
- K953845 — ABUSCREEN ONLINE DRUG FREE URINE
- K952412 — DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
- K951817 — ELI URINE CONTROLS
- K952056 — IMMUNOASSAY DRUGS OF ABUSE CONTROLS
- K951135 — MULTI-DRUG CONTROL SET
- K950138 — DRUGS OF ABUSE CONTROLS
- K943999 — ABUSCREEN ONTRAK POSITIVE CONTROL
- K945194 — ABUSCREEN ONLINE CONTROLS
- K943422 — TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL
- K942551 — THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
- K942041 — NIDA-5/RT, DRUG OF ABUSE CONTROLS
- K942257 — DOA-PLUS, DRUGS OF ABUSE CONTROLS
- K942552 — THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
- K942114 — ROCHE TDM CALIBRATION VERIFICATION TEST SET
- K940433 — DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4
- K936166 — CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS
- K934498 — DOA LIQUID DRUGS OF ABUSE CONTROLS
- K934650 — CEDIA DAU CONTROLS
- K935285 — DRUGS OF ABUSE CONTROLS
- K935230 — EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
- K934062 — BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
- K932549 — ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
- K931125 — ABUSCREEN ONLINE CONTROL
- K932643 — LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
- K931105 — PROCHECK(TM) BLIND PERFORMANCE SPECIMENS
- K930269 — COBAS-FP TDM CONTROLS
- K925586 — DETECTABUSE(TM)
- K920477 — DRUG OF ABUSE URINE CONTROL
- K914170 — LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
- K914806 — ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
- K913309 — TDM I LINEARITY TEST SET
- K913650 — DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL
- K911724 — ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
- K910930 — ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
Data sourced from openFDA. This site is unofficial and independent of the FDA.