Randox Toxicology

FDA Filings

This page includes the latest FDA filings for Randox Toxicology. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009473133
FEI Number3009473133
NameRANDOX TOXICOLOGY
Owner & OperatorRANDOX LABORATORIES, LTD.
Contact Address55 DIAMOND RD. --
CRUMLIN, CO.ANTRIM GB-NOTA BT29 4QY GB
Official Correspondent
  • PAULINE - ARMSTRONG
  • 44-28-90 422413-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address30 CHERRYVALLEY ROAD
CRUMLIN, CO. ANTRIM Northern Ireland, BT29 4QN GB
Establishment TypeExport Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Opiates Assay2012-09-03
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Opiates Assay2012-09-03
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Opiates Assay2012-09-03
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Cocaine Metabolite Assay, Calibrator set & Controls2012-06-29
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Cocaine Metabolite Assay, Calibrator set & Controls2012-06-29
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Cocaine Metabolite Assay, Calibrator set & Controls2012-06-29
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Ecstasy (MDMA) Assay, calibrators and controls2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Ecstasy (MDMA) Assay, calibrators and controls2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Ecstasy (MDMA) Assay, calibrators and controls2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Cannabinoids Assay, calibrator set and controls2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Cannabinoids Assay, calibrator set and controls2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Cannabinoids Assay, calibrator set and controls2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox barbiturates Assay, multidrug calibrator set & contro2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox barbiturates Assay, multidrug calibrator set & contro2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox barbiturates Assay, multidrug calibrator set & contro2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox methamphetamine Assay2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox methamphetamine Assay2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox methamphetamine Assay2011-07-11
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Benzodiazepine Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Benzodiazepine Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Benzodiazepine Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Ethanol Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Ethanol Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Ethanol Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Methadone Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Methadone Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Methadone Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Methadone Matabolite (EDDP) Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Methadone Matabolite (EDDP) Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Randox Methadone Matabolite (EDDP) Assay2010-12-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
TDM Calibrators2007-09-13
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX THERAPEUTIC DRUG CALIBRATORS2007-09-13
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX BENZODIAZIPINE CLASS ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE BENZODIAZIPINE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX BENZODIAZIPINE CLASS ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE BENZODIAZIPINE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX PHENCYCLIDINE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE PHENCYCLIDINE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX PHENCYCLIDINE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE PHENCYCLIDINE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX OPIATES ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE OPIATES ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX OPIATES ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE OPIATES ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX BARBITURATE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Evidence Barbiturate Assay2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX BARBITURATE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Evidence Barbiturate Assay2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX CANNABINOIDS ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE CANNABINOIDS ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX CANNABINOIDS ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE CANNABINOIDS ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX METHADONE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE METHADONE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX METHADONE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE METHADONE ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX AMPHETAMINE CLASS ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Evidence Amphetamine Class Assay2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX AMPHETAMINE CLASS ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Evidence Amphetamine Class Assay2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX AMPHETAMINE CLASS ASSAY2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Evidence Amphetamine Class Assay2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX GENTAMICIN2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX VALPROIC ACID2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX CARBAMAZEPINE2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX PHENOBARBITAL2007-08-01
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX PHENYTOIN2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Evidence Automated Test System2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE DRUGS OF ABUSE CALIBRATORS2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE COCAINE TEST SYSTEM2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE AUTOMATED2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX PHENYTOIN2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Evidence Automated Test System2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE DRUGS OF ABUSE CALIBRATORS2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE COCAINE TEST SYSTEM2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE AUTOMATED2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX PHENYTOIN2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
Evidence Automated Test System2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE DRUGS OF ABUSE CALIBRATORS2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE COCAINE TEST SYSTEM2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
EVIDENCE AUTOMATED2007-07-31
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX THEOPHYLLINE2006-09-08
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX PHENYTOIN2004-10-22
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RANDOX HUMAN ASSAYED DRUG CONTROL2004-10-19
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RX IMOLA2004-03-16
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RX IMOLA2004-03-16
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RX IMOLA2004-03-16
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RX IMOLA2004-03-16
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RX IMOLA2004-03-16
RANDOX TOXICOLOGY [RANDOX LABORATORIES, LTD.]
RX DAYTONA2004-02-09

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