Other products from "CLIAWAIVED, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00816610020440 CLIA-TSH-120-A-KIT CLIA-TSH-120-A-KIT CLIAWaived Inc. Thyroid Test Rapid TSH cassette (whole blood) CLIAWAIVED INC
2 00816610020402 THYROCHEK-120-A-KIT THYROCHEK-120-A-KIT Thyrochek One-Step Whole Blood Rapid TSH Assay CLIAWAIVED INC
3 00183278000443 CLIA-INGM-MC42S CLIA-INGM-MC42S CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Prof CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Professional Use Only" (Single kit includes 1 device, 1 lancets, 1 dropper, 1 single use buffer, 1 alcohol wipe, 1 procedure card and insert) CLIAWAIVED INC
4 00183278000436 CLIA-INGM-MC42 CLIA-INGM-MC42 CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 insert, 1 procedure card) CLIAWAIVED INC
5 00816610020242 CLIA-SDDT-22 CLIA-SDDT-22 Single Drug Dipstick Test for MDMA500 DJC Thin Layer Chromatography, Methamphetamine 2 CLIAwaived
6 00816610021058 CLIA-12-RDTC-A CLIA-12-RDTC-A Rapid Drug Test Cup for (THC/COC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AM Rapid Drug Test Cup for (THC/COC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Adulteration Tests CR, NI, PH, BL, SG LAF,LDJ,DIO,DJG,DJC,DKZ,JXM,LFG,LCM,DIS,DJR Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cannabinoids,Enzyme Immu Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Opiates,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Benzodiazepine,Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Phencyclidine,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Methadone 2 CLIAwaived
7 00816610020938 CLIA-IDTC-7BUP CLIA-IDTC-7BUP CLIAwaived,Inc. IDTC- 7 Panel Drug Screen (CR,SG,OX) for (COC/MET/MOP/MTD/BZO/OXY/BUP) JXM,DJR,DJG,LAF,DIO Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Methadone,Enzyme Immunoas Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
8 00816610020921 CLIA-IDTC-7-60717 CLIA-IDTC-7-60717 CLIAwaived,Inc. One Step Drug Test Cup-7 panel configuration (THC,COC,OPI 300,mA CLIAwaived,Inc. One Step Drug Test Cup-7 panel configuration (THC,COC,OPI 300,mAMP,MTD,OXY, BZO) -(25T/KIT) JXM,DJR,LAF,DJG,DIO,LDJ Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Methadone,Gas Chromatogra Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Methadone,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids 2 CLIAwaived
9 00816610020914 CLIA-IDTC-6-60669 CLIA-IDTC-6-60669 CLIAwaived,Inc. One Step Drug Test Cup-6 panel configuration (OPI300,BZO,BAR,MTD CLIAwaived,Inc. One Step Drug Test Cup-6 panel configuration (OPI300,BZO,BAR,MTD,OXY, TCA) -(25T/KIT) LFG,DJR,DIS,JXM,DJG Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,E Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates 2 CLIAwaived
10 00816610020884 CLIA-IDTC-5-65569 CLIA-IDTC-5-65569 CLIAwaived,Inc. One Step Drug Test Cup-5 panel with Adulterants (COC,OPI300,mAMP CLIAwaived,Inc. One Step Drug Test Cup-5 panel with Adulterants (COC,OPI300,mAMP,OXY, MTD + Cr, SG, OX) -(25T/KIT) DJR,LAF,DJG,DIO Enzyme Immunoassay, Methadone,Gas Chromatography, Methamphetamine,Enzyme Immunoa Enzyme Immunoassay, Methadone,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
11 00816610020860 CLIA-IDTC-5-60527 CLIA-IDTC-5-60527 CLIAwaived,Inc. IDTC- 5 Panel Cup (COC 300,MET 1000,OPI 300, OXY 100, THC 50)-(25T/KIT) LDJ,DJG,LAF,DIO Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Gas Chromatography, Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
12 00816610020846 CLIA-IDTC-5-60579 CLIA-IDTC-5-60579 CLIAwaived,Inc. IDTC- 5 Panel Drug Test Cup (COC,mAMP,OPI300, OXY, MTD)-(25T/KIT) DJR,DJG,LAF,DIO Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates,Gas Chromatography, Me Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
13 00816610020822 CLIA-IDTC-5-60527a CLIA-IDTC-5-60527a CLIAwaived,Inc. IDTC- 5 Panel Cup with Adulterants (CR, SG, OX) (COC 300,MET 100 CLIAwaived,Inc. IDTC- 5 Panel Cup with Adulterants (CR, SG, OX) (COC 300,MET 1000,OPI 300, OXY 100, THC 50)-(25T/KIT) LDJ,DJG,LAF,DIO Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Gas Chromatography, Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
14 00816610020808 CLIA-IDTC-12BUPa CLIA-IDTC-12BUPa CLIAwaived,Inc. IDTC- 12 Panel Cup with Adulterants (THC, COC, OPI 300, AMP, mAM CLIAwaived,Inc. IDTC- 12 Panel Cup with Adulterants (THC, COC, OPI 300, AMP, mAMP, PCP, BAR, BZO, MTD, OXY, MDMA, BUP + Cr, SG, OX)-(25T/KIT) DJR,JXM,DIS,LCM,LAF,DKZ,DJG,DIO,LDJ Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoas Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Phencyclidine,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids 2 CLIAwaived
15 00816610020785 CLIA-IDTC-11-NTHC CLIA-IDTC-11-NTHC CLIAwaived,Inc. IDTC- 11 Panel Cup with no THC (COC, OPI 300, AMP, mAMP, PCP, BA CLIAwaived,Inc. IDTC- 11 Panel Cup with no THC (COC, OPI 300, AMP, mAMP, PCP, BAR, BZO, MTD, OXY, MDMA, TCA)-(25T/KIT) LFG,DJR,JXM,DIS,LCM,LAF,DKZ,DJG,DIO Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,E Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Phencyclidine,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
16 00816610020662 CLIA-RDTC-12-02 CLIA-RDTC-12-02 Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDM Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) DKZ,LCM,LFG,DJR,DJG,DJC,LDJ,DIO,DIS,JXM Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Phencyclidine,Radioimmunoass Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Phencyclidine,Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine 2 CLIAwaived
17 00816610020655 CLIA-RDTC-12 CLIA-RDTC-12 Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDM Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) Includes adulterant testing for Creatinine, Nitrite, pH, Bleach and SG DKZ,LCM,LFG,DJR,DJG,DJC,LDJ,DIO,DIS,JXM Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Phencyclidine,Radioimmunoass Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Phencyclidine,Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine 2 CLIAwaived
18 00816610020648 CLIA-SDDT-QF10 CLIA-SDDT-QF10 Single Drug Dipstick Test for THC50/COC300/OPI300/MTD300 DJR,DJG,DIO,LDJ Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Co Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids 2 CLIAwaived
19 00816610020631 CLIA-SDDT-QF09 CLIA-SDDT-QF09 Single Drug Dipstick Test for THC50/COC300/OPI300/BZO300 JXM,DJG,DIO,LDJ Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates,Enzyme Immunoassa Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids 2 CLIAwaived
20 00816610020624 CLIA-SDDT-QF08 CLIA-SDDT-QF08 Single Drug Dipstick Test for BZO300/BAR300/MTD300/OXY100 DJG,DJR,DIS,JXM Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Ba Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine 2 CLIAwaived
21 00816610020266 CLIA-SDDT-25 CLIA-SDDT-25 Single Drug Dipstick Test for BUP10 DJG Enzyme Immunoassay, Opiates 2 CLIAwaived
22 00816610020259 CLIA-SDDT-23 CLIA-SDDT-23 Single Drug Dipstick Test for OXY100 DJG Enzyme Immunoassay, Opiates 2 CLIAwaived
23 00816610020235 CLIA-SDDT-21 CLIA-SDDT-21 Single Drug Dipstick Test for TCA1000 LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs 2 CLIAwaived
24 00816610020228 CLIA-SDDT-20 CLIA-SDDT-20 Single Drug Dipstick Test for MTD300 DJR Enzyme Immunoassay, Methadone 2 CLIAwaived
25 00816610020204 CLIA-SDDT-18 CLIA-SDDT-18 Single Drug Dipstick Test for BZO300 JXM Enzyme Immunoassay, Benzodiazepine 2 CLIAwaived
26 00816610020198 CLIA-SDDT-17 CLIA-SDDT-17 Single Drug Dipstick Test for PCP25 LCM Enzyme Immunoassay, Phencyclidine U CLIAwaived
27 00816610020181 CLIA-SDDT-16 CLIA-SDDT-16 Single Drug Dipstick Test for MET500 DJC Thin Layer Chromatography, Methamphetamine 2 CLIAwaived
28 00816610020174 CLIA-SDDT-14 CLIA-SDDT-14 Single Drug Dipstick Test for AMP1000 DKZ Enzyme Immunoassay, Amphetamine 2 CLIAwaived
29 00816610020167 CLIA-SDDT-13 CLIA-SDDT-13 Single Drug Dipstick Test for OPI300 DJG Enzyme Immunoassay, Opiates 2 CLIAwaived
30 00816610020150 CLIA-SDDT-11 CLIA-SDDT-11 Single Drug Dipstick Test for COC300 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
31 00816610020143 CLIA-SDDT-10 CLIA-SDDT-10 Single Drug Dipstick Test for THC50 LDJ Enzyme Immunoassay, Cannabinoids 2 CLIAwaived
32 00816610020136 X07-CLIA-RDDT-88 X07-CLIA-RDDT-88 Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/M Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500/BUP10 DJR,DIS,JXM,LCM,DKZ,LDJ,DJC,DJG,DIO Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Phencyclidine,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cannabinoids,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
33 00816610020129 X07-CLIA-RDDT-70 X07-CLIA-RDDT-70 Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/M Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500 DJR,DIS,JXM,LCM,DKZ,LDJ,DJC,DJG,DIO Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Phencyclidine,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cannabinoids,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
34 00816610020112 CLIA-RDDT-54 CLIA-RDDT-54 Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/PCP25/BZO300/MTD300/OXY100/BUP10 DJR,JXM,LCM,LDJ,DJC,DJG,DIO Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoas Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Phencyclidine,Enzyme Immunoassay, Cannabinoids,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
35 00816610020105 CLIA-RDDT-52 CLIA-RDDT-52 Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100 DJR,DIS,JXM,DKZ,LDJ,DJC,DJG,DIO Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cannabinoids,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
36 00816610020099 CLIA-RDDT-52A CLIA-RDDT-52A Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/ Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100 + CR/NI/PH/OX DJR,DIS,JXM,DKZ,LDJ,DJC,DJG,DIO Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cannabinoids,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
37 00816610020082 CLIA-14-RDTC-A CLIA-14-RDTC-A Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD3 Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000)(MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG DJR,DIS,JXN,LCM,LFG,JXM,DKZ,DJC,DJG,DIO,LDJ Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Propoxyphene,Enzyme Immunoassay, Phencyclidine,Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Amphetamine,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids 2 CLIAwaived
38 00816610020075 CLIA-RDDT-13 CLIA-RDDT-13 Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/BZO300 JXM,LDJ,DJC,DJG,DIO Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Cannabinoids,Thin Layer C Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Cannabinoids,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 CLIAwaived
39 00816610020068 CLIA-12-RDTC-BUP-A CLIA-12-RDTC-BUP-A Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD3 Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000)(MDMA500/OXY100) + CR, NI, PH, BL, SG LFG,DJR,DIS,JXM,DKZ,DJC,DJG,DIO,LDJ Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,E Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Amphetamine,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids 2 CLIAwaived
Other products with the same Product Code "DIS"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00884883012820 10017365 CEDIA Barbiturate Assay MICROGENICS CORPORATION
2 00884883011656 10015648 DRI Barbiturate Assay MICROGENICS CORPORATION
3 00884883005587 0911 DRI Barbiturate Serum Tox Assay MICROGENICS CORPORATION
4 00884883004092 1661213 CEDIA DAU Barbiturate Assay MICROGENICS CORPORATION
5 00884883002838 0226 DRI Barbiturate Assay MICROGENICS CORPORATION
6 00884883002616 0225 DRI Barbiturate Assay MICROGENICS CORPORATION
7 00884883001473 100093 CEDIA Barbiturate Assay MICROGENICS CORPORATION
8 00884883001411 100084 CEDIA Barbiturate Assay MICROGENICS CORPORATION
9 00868754000208 X13-DT13A X13-DT13A THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA5 THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 w/ Cr,Ni,pH,Bl,S.G. drugs of abuse test cup Coastline Explorer Cup COASTLINE MEDICAL MANAGEMENT, LLC
10 00868401000261 RC10TCA RC10TCA (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G. RealityCHECK Drugs of Abuse Cup WOLFE & ASSOCIATES INC
11 00868401000254 RC12TCA RC12TCA (BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G. RealityCHECK Drugs of Abuse Cup WOLFE & ASSOCIATES INC
12 00868348000256 65C13+4 Status Toxi-Cup 13 panel drug cup with 4 adulterations - AMP 1000, BAR 300, BUP Status Toxi-Cup 13 panel drug cup with 4 adulterations - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 2000, OXY 100, PCP 25, TCA 1000, THC 50 + pH/CRE/NBP/SG Status Toxi Cup LIFESIGN L.L.C.
13 00868348000232 71125AA2K 71125AA2K MET1000+OPI2000+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl MET1000+OPI2000+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup Status ASSURE LIFESIGN L.L.C.
14 00868348000225 71125AA 71125AA MET1000+OPI300+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, MET1000+OPI300+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup Status ASSURE LIFESIGN L.L.C.
15 00868348000218 11125AA2K 11125AA2K (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI2000+TCA with Cr, Ni, pH, Bl (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI2000+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card Status ASSURE LIFESIGN L.L.C.
16 00868348000201 11125AA 11125AA (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card Status ASSURE LIFESIGN L.L.C.
17 00867802000290 BS-0610S 301 The xReader System consists of a small, portable high resolution flatbed scanner The xReader System consists of a small, portable high resolution flatbed scanner, customized Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The xReader System is intended for use with the xCup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine.The xReader System detects drug classes at the following cutoff concentrations: Amphetamines at 500 ng/mL; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCup may consist of any combination of the listed drug analytes.The xCup test devices are run in the xReader System according to their specific instructions for use. At the conclusion of the test an image is captured and the Software determines whether the colored test lines for each analyte are above or below the threshold associated with a Send to Lab or a Discard result. The Software also confirms the validity of the results by verifying the presence of control lines and analyzing the specimen validity. The xReader System is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use. The xCup test devices cannot be read visually. xReader System ESCREEN, INC.
18 00863480002113 65C12+4 Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD300MET1000MDMA500OPI2000OXY100PCP25TCA1000BUP10 Adulterants - CRE, pH, SG, NBP Status Toxi Cup 13+4 LIFESIGN L.L.C.
19 00863480002106 60B02 LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml LifeSign QuikScreen 11 LIFESIGN L.L.C.
20 00860113002052 MDC-694 CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP) MD DrugScreen MEDICAL DISPOSABLES CORP
21 00860113002045 M-DOA-694 CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP) MD DrugScreen MEDICAL DISPOSABLES CORP
22 00860113002038 M-DOA-694 CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP) MD DrugScreen MEDICAL DISPOSABLES CORP
23 00860113002021 M-DOA-694 CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP) MD DrugScreen MEDICAL DISPOSABLES CORP
24 00859144006313 30640D 30640D (BZO/BAR)+AMP+COC+OPI2000+THC DipCard DrugSmart Dip TWIN SPIRIT INC.
25 00859144006306 30530D 30530D AMP/BAR/COC/OPI2000/THC Dipcard DrugSmart Dip TWIN SPIRIT INC.
26 00859144006283 30510D 30510D AMP/BAR/BZO/COC/THC DipCard DrugSmart Dip TWIN SPIRIT INC.
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