| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00851721007652 | MDC-354 | LAF | Gas Chromatography, Methamphetamine | 2 | MD DugScreen | ||
| 2 | 00851721007034 | M-DOA-554 | CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-MET-MDMA) | LDJ | Enzyme Immunoassay, Cannabinoids | 2 | MD DugScreen | |
| 3 | 00851721007027 | M-DOA-264 | CLIA Waived 6 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-BZO) | LDJ | Enzyme Immunoassay, Cannabinoids | 2 | MD DugScreen | |
| 4 | 00851721007010 | M-DOA-254 | CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-AMP-MET) | LDJ | Enzyme Immunoassay, Cannabinoids | 2 | MD DugScreen | |
| 5 | 00851721007003 | M-DOA-244 | CLIA Waived 4 Panel Drug Test Card-(THC-COC-OPI-AMP) | DKZ | Enzyme Immunoassay, Amphetamine | 2 | MD DugScreen | |
| 6 | 00850969007875 | MDC-7104AD | CLIA Waived Drug Test Cup w/ 6 Adulterants -(THC-COC-OPI-MET-BZO-BAR-MTD-TCA-OXY-BUP) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DugScreen | |
| 7 | 00850969007998 | M-DOA-234 | CLIA Waived 3 Panel Drug Test Card-(THC-COC-MET) | LDJ | Enzyme Immunoassay, Cannabinoids | 2 | MD DugScreen | |
| 8 | 00850969007981 | M-DOA-164 | CLIA Waived 6 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP) | LCM | Enzyme Immunoassay, Phencyclidine | U | MD DugScreen | |
| 9 | 00850969007974 | M-DOA-154 | CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-AMP-PCP) | LCM | Enzyme Immunoassay, Phencyclidine | U | MD DugScreen | |
| 10 | 00850969007967 | M-DOA-144 | CLIA Waived 4 Panel Drug Test Card-(THC-COC-OPI-MET) | LAF | Gas Chromatography, Methamphetamine | 2 | MD DugScreen | |
| 11 | 00850969007943 | M-DOA-1124 | CLIA Waived 12 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP-BZ0-BAR-MTD-MDMA-OXY-PPX) | LCM | Enzyme Immunoassay, Phencyclidine | U | MD DugScreen | |
| 12 | 00850969007936 | M-DOA-1104 | CLIA Waived 10 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP-BZ0-BAR-MTD-TCA) | LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 2 | MD DugScreen | |
| 13 | 00850969007929 | M-DMO-114 | CLIA Waived Morphine 300 ng/ml Test Panel (MOP) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DugScreen | |
| 14 | 00850969007912 | M-DMA-114 | CLIA Waived Methamphetamine Test Panel (MET) | LAF | Gas Chromatography, Methamphetamine | 2 | MD DugScreen | |
| 15 | 00850969007905 | M-DCO-114 | CLIA Waived Cocaine Test Panel (COC) | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | MD DugScreen | |
| 16 | 00850969007899 | MDC-8145 | CLIA Waived Drug Test Cup-(THC-COC150-MOP-AMP500-MET500-PCP-BZO-BAR-MDMA-MTD-OXY CLIA Waived Drug Test Cup-(THC-COC150-MOP-AMP500-MET500-PCP-BZO-BAR-MDMA-MTD-OXY-BUP-TCA-EDDP) | DJR | Enzyme Immunoassay, Methadone | 2 | MD DugScreen | |
| 17 | 00850969007882 | MDC-8104 | CLIA Waived Drug Test Cup-(THC-COC-OPI-MET-AMP-BZO-MTD-MDMA-OXY-BUP) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DugScreen | |
| 18 | 00850969007868 | MDC-7104 | CLIA Waived Drug Test Cup-(THC-COC-OPI-MET-BZO-BAR-MTD-TCA-OXY-BUP) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DugScreen | |
| 19 | 00850969007851 | MDC-654AD | CLIA Waived Drug Test Cup w/ 6 Adulterants-(THC-COC-OPI-MET-BZO) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DugScreen | |
| 20 | 00860146001596 | MDC-585-AD | CLIA Waived 8 Panel Cup w/6-AD(THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/ CLIA Waived 8 Panel Cup w/6-AD(THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/PCP25)+ (NIT-GLUT-CRE/OXI-SG-PH) | LAF | Gas Chromatography, Methamphetamine | 2 | MD DrugScreen | |
| 21 | 00860146001589 | MDC-3135 | CLIA Waived Drug Test Cup (THC-COC-MOP-AMP-MET-PCP-BZO-TCA-BAR-OXY-PPX-BUP-MTD) | LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 2 | MD DrugScreen | |
| 22 | 00850969007844 | MDC-654 | CLIA Waived Drug Test Cup-(THC-COC-OPI-MET-BZO) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DugScreen | |
| 23 | 00860146001572 | MDC-3135 | CLIA Waived Drug Test Cup (THC-COC-MOP-AMP-MET-PCP-BZO-TCA-BAR-OXY-PPX-BUP-MTD) | LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 2 | MD DrugScreen | |
| 24 | 00860146001565 | MDC-3135 | CLIA Waived Drug Test Cup (THC-COC-MOP-AMP-MET-PCP-BZO-TCA-BAR-OXY-PPX-BUP-MTD) | LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 2 | MD DrugScreen | |
| 25 | 00851721007973 | MDC-8104ALC | CLIA Waived Drug Test Cup-(THC/COC/OPI/MET/AMP/BZO/MTD/OXY/MDMA/BUP)+ Alcohol | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DrugScreen | |
| 26 | 00851721007966 | M-DOA-565 | M-DOA-565 CLIA Waived 6 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DrugScreen | |
| 27 | 00851721007959 | M-DOA-565 | M-DOA-565 CLIA Waived 6 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DrugScreen | |
| 28 | 00851721007942 | M-DOA-565 | M-DOA-565 CLIA Waived 6 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DrugScreen | |
| 29 | 00851721007935 | M-DOP-114 | CLIA Waived Opiates Test Panel (OPI) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DrugScreen | |
| 30 | 00851721007928 | M-DOP-114 | CLIA Waived Opiates Test Panel (OPI) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DrugScreen | |
| 31 | 00851721007911 | M-DOP-114 | CLIA Waived Opiates Test Panel (OPI) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DrugScreen | |
| 32 | 00850969007837 | MDC-6125AD | CLIA Waived Drug Test Cup w/ 6 Adulterants-(THC-COC-MOP-AMP-MET-PCP-BZO-BAR-MDMA CLIA Waived Drug Test Cup w/ 6 Adulterants-(THC-COC-MOP-AMP-MET-PCP-BZO-BAR-MDMA-MTD-OXY-BUP) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DugScreen | |
| 33 | 00850969007820 | MDC-6125 | CLIA Waived Drug Test Cup-(THC-COC-MOP-AMP-MET-PCP-BZO-BAR-MDMA-MTD-OXY-BUP) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DugScreen | |
| 34 | 00851721007904 | MDC-12105-AD | CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-MOP-AMP-MET-BUP-MTD-MDMA-PCP- CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-MOP-AMP-MET-BUP-MTD-MDMA-PCP-OXY)+(NIT-GLUT-CRE/OXI-SG-PH) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DrugScreen | |
| 35 | 00851721007898 | MDC-12105-AD | CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-MOP-AMP-MET-BUP-MTD-MDMA-PCP- CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-MOP-AMP-MET-BUP-MTD-MDMA-PCP-OXY)+(NIT-GLUT-CRE/OXI-SG-PH) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DrugScreen | |
| 36 | 00850969007813 | MDC-4125 | CLIA Waived Drug Test Cup-(THC-COC-MOP-AMP-MET-PCP-BZO-BAR-PPX-MTD-OXY-BUP) | LCM | Enzyme Immunoassay, Phencyclidine | U | MD DugScreen | |
| 37 | 00851721007881 | MDC-12105-AD | CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-MOP-AMP-MET-BUP-MTD-MDMA-PCP- CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-MOP-AMP-MET-BUP-MTD-MDMA-PCP-OXY)+(NIT-GLUT-CRE/OXI-SG-PH) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DrugScreen | |
| 38 | 00851721007874 | MDC-1135 | CLIA Waived Drug Test Cup (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP/TCA) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DrugScreen | |
| 39 | 00850969007806 | MDC-4104AD | CLIA Waived Drug Test Cup w/ 6 Adulterants-(THC-COC-OPI-AMP-MET-PCP-BZO-BAR-MTD-OXY) | DIS | Enzyme Immunoassay, Barbiturate | 2 | MD DugScreen | |
| 40 | 00851721007867 | MDC-6125-A3 | CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/O CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/OXY/MDMA/BUP) +(OXI-SG-PH) | DKZ | Enzyme Immunoassay, Amphetamine | 2 | MD DrugScreen | |
| 41 | 00851721007850 | M-DOA-824 | CLIA Waived 2 Panel Drug Test Card (BUP/TCA) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DrugScreen | |
| 42 | 00851721007843 | MDC-1135 | CLIA Waived Drug Test Cup (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP/TCA) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DrugScreen | |
| 43 | 00851721007836 | MDC-6125-A3 | CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/O CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/OXY/MDMA/BUP) +(OXI-SG-PH) | DKZ | Enzyme Immunoassay, Amphetamine | 2 | MD DrugScreen | |
| 44 | 00851721007829 | MDC-1135 | CLIA Waived Drug Test Cup (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP/TCA) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DrugScreen | |
| 45 | 00850969007790 | MDC-4104 | CLIA Waived Drug Test Cup-(THC-COC-OPI-AMP-MET-PCP-BZO-BAR-MTD-OXY) | DIS | Enzyme Immunoassay, Barbiturate | 2 | MD DugScreen | |
| 46 | 00850969007783 | MDC-375AD | CLIA Waived Drug Test Cup w/ 6 Adulterants-(THC-COC-MOP-MET-BZO-OXY-BUP) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DugScreen | |
| 47 | 00850969007776 | MDC-375 | CLIA Waived Drug Test Cup-(THC-COC-MOP-MET-BZO-OXY-BUP) | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | MD DugScreen | |
| 48 | 00851721007812 | MDC-6125-A3 | CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/O CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/OXY/MDMA/BUP) +(OXI-SG-PH) | DKZ | Enzyme Immunoassay, Amphetamine | 2 | MD DrugScreen | |
| 49 | 00851721007805 | M-DOA-824 | CLIA Waived 2 Panel Drug Test Card (BUP/TCA) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DrugScreen | |
| 50 | 00851721007799 | M-DOA-375 | CLIA Waived 7 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY-BUP) | DJG | Enzyme Immunoassay, Opiates | 2 | MD DugScreen |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00812203030605 | C-60930D | DrugSmart Cup 9 CLIA-Waived, AMP/COC/OPI2K/MET/PCP/BAR/BZO/PPX/MTD, 25tests/kit | DrugSmart Cup 9 | CHEMTRON BIOTECH INC | |
| 2 | 00812203030582 | PCA-6M2S-20 | 6 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH) | Premier Biotech | CHEMTRON BIOTECH INC | |
| 3 | 00812203030551 | 712E14-CT | Chemtrue 5-Panel DOA Cup, AMP500/COC150/MET500/OPI/PCP/(Cr/SG/Ox/Ni/pH/Gl) | Chemtrue | CHEMTRON BIOTECH INC | |
| 4 | 00812203030520 | 712L17A-CT | Chemtrue 12-Panel DOA Cup Test, AMP/BAR/BUP/BZO/COC150/MDMA/MET/MTD/OPI/OXY/PCP/ Chemtrue 12-Panel DOA Cup Test, AMP/BAR/BUP/BZO/COC150/MDMA/MET/MTD/OPI/OXY/PCP/THC + A-strip (Cr/Ox/pH) | Chemtrue | CHEMTRON BIOTECH INC | |
| 5 | 00812203030513 | 711G05A-CT | Chemtrue 7-Panel DOA Dip Card, BZO/COC150/MET500/MOR/OXY/PCP/THC (Ni/pH/Gl)(Cr/SG/Ox) | Chemtrue | CHEMTRON BIOTECH INC | |
| 6 | 00812203030490 | PCA-12PXS-ALT | 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (O 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Ox/pH/SG) - PB | Premier Biotech | CHEMTRON BIOTECH INC | |
| 7 | 00812203030483 | 712G07A-CT | 7-Panel Chemtrue DOA Cup, AMP/COC/MET500/OPI300/OXY/PCP/THC + (Cr/SG/Ox)(Ni/pH/Gl) | Chemtrue | CHEMTRON BIOTECH INC | |
| 8 | 00812203030377 | 711K04-OS | OSTS 11-Panel DOA Dip Test AMP500/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR/OXY/PCP | OSTS | CHEMTRON BIOTECH INC | |
| 9 | 00812203030353 | PCA-12PXS-LC | 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (C 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH) - PB | Premier Biotech | CHEMTRON BIOTECH INC | |
| 10 | 00812203030322 | 711K03-G | 11-Panel Drug Screen Dip - AMP/BAR/BZO/COC/MET/MDMA/MOR/MTD/OXY/PCP/TCA | Generic | CHEMTRON BIOTECH INC | |
| 11 | 00812203030315 | PCA-14MP3-LC | 14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX | Premier Biotech | CHEMTRON BIOTECH INC | |
| 12 | 00812203030261 | 712L16A-G | 12-Panel DOA Cup, AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH) | Generic | CHEMTRON BIOTECH INC | |
| 13 | 00812203030216 | 712L15A-G | 12-Panel DOA Cup, AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI300/OXY/PCP/PPX/THC (Cr/SG/Bl) | Generic | CHEMTRON BIOTECH INC | |
| 14 | 00812203030186 | 712N04-G | 14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX | Generic | CHEMTRON BIOTECH INC | |
| 15 | 00812203030179 | C-31223D | 12-Panel DrugSmart Dip, AMP300/MOR/COC150/THC/MET500/PCP/BAR/BZO/MTD/MDMA/OXY/BUP | DrugSmart Dip 12 | CHEMTRON BIOTECH INC | |
| 16 | 00812203030148 | 712L14 | 12-Panel DOA Cup, COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BAR/BZO | Generic | CHEMTRON BIOTECH INC | |
| 17 | 00812203030124 | 60565D | DrugSmart Cup 5, AMP/COC/OPI/OXY/THC, 25 tests/kit | DrugSmart Cup 5 | CHEMTRON BIOTECH INC | |
| 18 | 00812203030100 | 711J11 | 10-Panel Drug Screen Dip - AMP/BAR/BZO/COC/THC/MTD/MOR/OXY/PCP/PPX | Generic | CHEMTRON BIOTECH INC | |
| 19 | 00812203030087 | 712L13 | 12-Panel DOA Cup, THC/COC150/MOR/AMP500/MET500/BAR/BZO/BUP/MTD/MDMA/OXY/PCP | Generic | CHEMTRON BIOTECH INC | |
| 20 | 00812203030063 | C-61130D | DrugSmart Cup 11, THC/COC/MOR/MET/AMP/BZO/BAR/MTD/BUP/MDMA/OXY, 25 tests/kit | DrugSmart Cup 11 | CHEMTRON BIOTECH INC | |
| 21 | 00812203030056 | 712M06 | 13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MET/MTD/OPI2000/OXY/PCP/PPX/TCA/THC - 25 tests/kit | Generic | CHEMTRON BIOTECH INC | |
| 22 | 00812203030049 | 712J08 | 10-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/MOR/PCP/PPX/THC - 25tests/kit | Generic | CHEMTRON BIOTECH INC | |
| 23 | 00812203030032 | 712E09 | 5-Panel DOA Cup Test, MTD/MOR/BUP/BZO/OXY, 25 tests/kit | Generic | CHEMTRON BIOTECH INC | |
| 24 | 00812203030025 | 712G03A | 7-Panel DOA Cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25tests/kit | Generic | CHEMTRON BIOTECH INC | |
| 25 | 00812203030018 | 712E04A | 5-Panel DOA Cup, AMP/COC/MET/OPI2000/THC /A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25tests/kit | Generic | CHEMTRON BIOTECH INC | |
| 26 | 00812203030001 | 712C04A | 3-Panel DOA Cup, COC/THC/OPI2000/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25 tests/kit | Generic | CHEMTRON BIOTECH INC | |
| 27 | 00812101030769 | 10028871 | 10028871 | The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the q The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. | DRI™ Fentanyl II Assay - 500mL | ARK DIAGNOSTICS INC |
| 28 | 00812101030752 | 10028872 | 10028872 | The DRI™ Fentanyl II Assay is an immunoassay intended for the qualitative detec The DRI™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. | DRI™ Fentanyl II Assay | ARK DIAGNOSTICS INC |
| 29 | 00812101030622 | 5072-0001-00 | 5072-0001-00 | The ARK™ Fentanyl II Assay is a homogeneous enzyme immunoassay intended for the The ARK™ Fentanyl II Assay is a homogeneous enzyme immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 0.5 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl in urine on automated clinical chemistry analyzers. | ARK™ Fentanyl II Assay - 500mL (WPT) | ARK DIAGNOSTICS INC |
| 30 | 00812101030585 | 5069-0001-02 | 5069-0001-02 | The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative deter The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. | ARK™ Fentanyl II Assay - 500mL | ARK DIAGNOSTICS INC |
| 31 | 00812101030578 | 5069-0001-01 | 5069-0001-01 | The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative detec The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. | ARK™ Fentanyl II Assay | ARK DIAGNOSTICS INC |
| 32 | 00812101030561 | 5069-0001-00 | 5069-0001-00 | The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative deter The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. | ARK™ Fentanyl II Assay | ARK DIAGNOSTICS INC |
| 33 | 00812101030134 | 5039-0001-01 | 5039-0001-01 | The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitati The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determination of meperidine in human urine at cutoff concentrations of 100 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only. | ARK™ Meperidine Assay | ARK DIAGNOSTICS INC |
| 34 | 00812101030127 | 5039-0001-00 | 5039-0001-00 | The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitati The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determination of meperidine in human urine at cutoff concentrations of 100 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only. | ARK™ Meperidine Assay | ARK DIAGNOSTICS INC |
| 35 | 00811727018229 | 60-AC0580-1L | 60-AC0580-1L | Pointe 6-Acetylmorphine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe 6-A Pointe 6-Acetylmorphine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe 6-Acetylmorphine Reagent Set is intended for the qualitative and semi-quantitative determination of 6-acetylmorphine in human urine at a cutoff value of 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe 6-Acetylmorphine Reagent Set | POINTE SCIENTIFIC, INC. |
| 36 | 00811727018212 | 60-AC0580-100 | 60-AC0580-100 | Pointe 6-Acetylmorphine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe 6-A Pointe 6-Acetylmorphine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe 6-Acetylmorphine Reagent Set is intended for the qualitative and semi-quantitative determination of 6-acetylmorphine in human urine at a cutoff value of 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe 6-Acetylmorphine Reagent Set | POINTE SCIENTIFIC, INC. |
| 37 | 00811727017451 | 60-OX0480-1L | 60-OX0480-1L | Pointe Oxycodone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Oxycodone Pointe Oxycodone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Oxycodone Reagent Set is intended for the qualitative and semi-quantitative determination of oxycodone in human urine, at cutoff values of 100 ng/mL and 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Oxycodone Reagent Set | POINTE SCIENTIFIC, INC. |
| 38 | 00811727017444 | 60-OX0480-100 | 60-OX0480-100 | Pointe Oxycodone Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Oxycodone Pointe Oxycodone Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Oxycodone Reagent Set is intended for the qualitative and semi-quantitative determination of oxycodone in human urine, at cutoff values of 100 ng/mL and 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Oxycodone Reagent Set | POINTE SCIENTIFIC, INC. |
| 39 | 00811727016959 | 60-OP0660-1L | 60-OP0660-1L | Pointe Opiates 2000 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates Pointe Opiates 2000 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates 2000 Reagent Set is intended for the qualitative and semi-quantitative determination of morphine in human urine at a cutoff value of 2000 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Opiates 2000 Reagent Set | POINTE SCIENTIFIC, INC. |
| 40 | 00811727016942 | 60-OP0660-100 | 60-OP0660-100 | Pointe Opiates 2000 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Opiates Pointe Opiates 2000 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Opiates 2000 Reagent Set is intended for the qualitative and semi-quantitative determination of morphine in human urine at a cutoff value of 2000 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Opiates 2000 Reagent Set | POINTE SCIENTIFIC, INC. |
| 41 | 00811727016874 | 60-OP0040-1L | 60-OP0040-1L | Pointe Opiates 300 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates Pointe Opiates 300 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates 300 Reagent Set is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. This assay is for prescription use only. | Pointe Opiates 300 Reagent Set | POINTE SCIENTIFIC, INC. |
| 42 | 00811727016867 | 60-OP0040-100 | 60-OP0040-100 | Pointe Opiates 300 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Opiates Pointe Opiates 300 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Opiates 300 Reagent Set is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. This assay is for prescription use only. | Pointe Opiates 300 Reagent Set | POINTE SCIENTIFIC, INC. |
| 43 | 00811727016775 | 60-HY0780-100 | 60-HY0780-100 | Pointe Hydrocodone 300 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Hydr Pointe Hydrocodone 300 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Hydrocodone 300 Reagent Set is intended for the qualitative and semi-quantitative determination of hydrocodone in human urine at a cutoff value of 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Hydrocodone 300 Reagent Set | POINTE SCIENTIFIC, INC. |
| 44 | 00811727016706 | 60-HY0760-1L | 60-HY0760-1L | Pointe Hydrocodone 100 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Hydr Pointe Hydrocodone 100 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Hydrocodone 100 Reagent Set is intended for the qualitative and semi-quantitative determination of hydrocodone in human urine at a cutoff value of 100 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Hydrocodone 100 Reagent Set | POINTE SCIENTIFIC, INC. |
| 45 | 00811727016690 | 60-HY0760-100 | 60-HY0760-100 | Pointe Hydrocodone 100 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Hydr Pointe Hydrocodone 100 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Hydrocodone 100 Reagent Set is intended for the qualitative and semi-quantitative determination of hydrocodone in human urine at a cutoff value of 100 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Hydrocodone 100 Reagent Set | POINTE SCIENTIFIC, INC. |
| 46 | 00811727016416 | 60-FN0620-1L | 60-FN0620-1L | Pointe Fentanyl (Qualitative) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Poin Pointe Fentanyl (Qualitative) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Fentanyl Reagent Set is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Fentanyl (Qualitative) Reagent Set | POINTE SCIENTIFIC, INC. |
| 47 | 00811727016409 | 60-FN0620-100 | 60-FN0620-100 | Pointe Fentanyl (Qualitative) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Poin Pointe Fentanyl (Qualitative) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Fentanyl Reagent Set is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Fentanyl (Qualitative) Reagent Set | POINTE SCIENTIFIC, INC. |
| 48 | 00811727016317 | 60-BP0540-1L | 60-BP0540-1L | Pointe Buprenorphine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Bupren Pointe Buprenorphine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Buprenorphine Reagent Set is intended for the qualitative and semi-quantitative determination of norbuprenorphine (a buprenorphine metabolite) in human urine at a cutoff value of 5 ng/mL and 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Buprenorphine Reagent Set | POINTE SCIENTIFIC, INC. |
| 49 | 00811727016300 | 60-BP0540-100 | 60-BP0540-100 | Pointe Buprenorphine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Bupren Pointe Buprenorphine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Buprenorphine Reagent Set is intended for the qualitative and semi-quantitative determination of norbuprenorphine (a buprenorphine metabolite) in human urine at a cutoff value of 5 ng/mL and 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Buprenorphine Reagent Set | POINTE SCIENTIFIC, INC. |
| 50 | 00810038633367 | EDOAP-1124 | EDOAP-1124-1 | 1 test kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX | Easy@Home Multi-Drug Screen Test (1 test kit) | EASY HEALTHCARE CORPORATION |