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

Enzyme Immunoassay, Cannabinoids

Regulation 862.3870

0510(k)s in 12 months (150 all time)
0recalls in 12 months (15 all time)
12recalls that name a 510(k)
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Top companies in LDJ

Company510(k)sRecalls
Syva Co.170
Roche Diagnostic Systems, Inc.110
Abbott Laboratories80
Ameditech, Inc.17
OraSure Technologies, Inc.24
Microgenics Corp.50
ACON Laboratories, Inc.40
Amedica Biotech, Inc.40
Diagnostic Products Corp.40
American Bio Medica Corp.30
DateFirm and productCodeLinked 510(k)
Nov 7, 2023Family Dollar Stores, Llc.
AT HOME MARIJUANA TEST STRIP, SKU 900752
Open, Classified		 LDJK140546
Aug 17, 2022Family Dollar Stores, Llc.
AT HOME MARIJUANA TEST STRIP, SKU 900752
Open, Classified		 LDJK140546
Aug 18, 2020Ameditech Inc
First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
Terminated		 LDJK122633
Aug 18, 2020Ameditech Inc
Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "
Terminated		 LDJNone listed
Aug 18, 2020Ameditech Inc
iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG1
Terminated		 LDJK122633
Aug 18, 2020Ameditech Inc
Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl,
Terminated		 LDJK122633
Aug 18, 2020Ameditech Inc
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni,
Terminated		 LDJK122633
Aug 18, 2020Ameditech Inc
Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS AMP500/BAR/BUPG/BZO/COC150/MDMA/MET
Terminated		 LDJK122633
Aug 18, 2020Ameditech Inc
CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-25 / "CLIA Waived" Inc. Single Drug Dipstick Test
Terminated		 LDJK122633
Feb 10, 2020Carolina Liquid Chemistries Corp
SPICE (JWH-018) CC443
Terminated		 LDJNone listed
Aug 23, 2013Sarken, Inc.
SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Terminated		 LDJNone listed
Dec 23, 2008OraSure Technologies, Inc.
Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit.
Terminated		 LDJK002375
Dec 23, 2008OraSure Technologies, Inc.
Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit.
Terminated		 LDJK002375
Dec 23, 2008OraSure Technologies, Inc.
Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit.
Terminated		 LDJK002375
Dec 18, 2008OraSure Technologies, Inc.
Cannabinoids Intercept Micro Plate EIA 100 plate kit
Terminated		 LDJK002375

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