ClearanceBrief
Panels › Clinical Toxicology › Product code DKZ · Class 2

Enzyme Immunoassay, Amphetamine

Regulation 862.3100

0510(k)s in 12 months (225 all time)
0recalls in 12 months (24 all time)
20recalls that name a 510(k)
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Top companies in DKZ

DateFirm and productCodeLinked 510(k)
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug P
Open, Classified
DKZK133968
K182701
Aug 18, 2020Ameditech Inc
First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B
Terminated
DKZK052115
Aug 18, 2020Ameditech Inc
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
Terminated
DKZK052115
Aug 18, 2020Ameditech Inc
First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
Terminated
DKZK052115
Nov 14, 2017Alere San Diego, Inc.
Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product
Completed
DKZK973784
Oct 16, 2014Ameditech Inc
ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites i
Terminated
DKZK113046
Oct 16, 2014Ameditech Inc
ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in
Terminated
DKZK113046
Oct 16, 2014Ameditech Inc
ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in hu
Terminated
DKZK113046
Jan 9, 2014Alere San Diego, Inc.
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Devic
Terminated
DKZNone listed
Aug 23, 2013Sarken, Inc.
SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Terminated
DKZNone listed
Aug 23, 2013Sarken, Inc.
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Terminated
DKZNone listed
Jan 11, 2012Alere San Diego
Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricycli
Terminated
DKZK973784
Nov 3, 2011Ameditech Inc
ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human uri
Terminated
DKZK052115
Jul 27, 2011Alere San Diego
Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.
Terminated
DKZK061718
Jun 27, 2011Ameditech Inc
SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a give
Terminated
DKZK042975
K050186
Oct 6, 2009Biosite Inc
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Terminated
DKZK061718
Oct 6, 2009Biosite Inc
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Terminated
DKZK061718
Oct 6, 2009Biosite Inc
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Terminated
DKZK061718
Oct 6, 2009Biosite Inc
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Terminated
DKZK061718
Oct 6, 2009Biosite Inc
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Terminated
DKZK061718
Mar 17, 2009Biosite Inc
Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.
Terminated
DKZK973784
Sep 26, 2008Medtox Diagnostics Inc
MEDTOXscan Reader
Terminated
DKZNone listed
May 14, 2008Abbott Laboratories
AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
Terminated
DKZK953115
Apr 10, 2007Bio-Rad Laboratories Inc
Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA
Terminated
DKZK031759

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