No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00884883002524 | 0017 | LAF,DKZ | Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Amphetamine | 2 | DRI Amphetamines Assay | ||
2 | 00884883001442 | 100088 | DJR | Enzyme Immunoassay, Methadone | 2 | CEDIA Methadone Assay | ||
3 | 00884883012547 | 10016425 | DJR | Enzyme Immunoassay, Methadone | 2 | CEDIA Methadone Assay | ||
4 | 00884883012684 | 10017205 | ORH | Lamotrigine Assay | 2 | QMS Lamotrigine Assay | ||
5 | 00884883011854 | 10015987 | OUF | Everolimus Immunoassay | 2 | QMS Everolimus Assay | ||
6 | 00884883011625 | 10015632 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
7 | 00884883011328 | 0374116 | DLJ | Calibrators, Drug Specific | 2 | QMS Tobramycin Immunoassay Calibrator Set | ||
8 | 00884883011229 | 0373373 | LAS | Drug Specific Control Materials | 1 | QMS Zonisamide Immunoassay Control Set | ||
9 | 00884883010987 | 10014957 | DKB | Calibrators, Drug Mixture | 2 | CEDIA Multi-Drug OFT Control Set | ||
10 | 00884883007529 | 10027482 | OHQ | Multi-Analyte Controls Unassayed | 1 | MAS anti-HBs Positive Control | ||
11 | 00884883007512 | 10027481 | OHQ | Multi-Analyte Controls Unassayed | 1 | MAS HIV p24 Positive Control | ||
12 | 00884883006966 | 10023647 | QDR | Plazomicin Test System, Immunoassay | 2 | QMS Plazomicin Immunoassay | ||
13 | 00884883006959 | 969035 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix Syphilis | ||
14 | 00884883006546 | 964003 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HIV-1 High Control | ||
15 | 00884883006478 | 964001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HIV-1 Low Control | ||
16 | 00884883006454 | 963001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HCV Low Control | ||
17 | 00884883006386 | 960041 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix GBS Positive Control | ||
18 | 00884883006027 | 963603 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix BB NAT HBV Positive Control | ||
19 | 00884883005969 | 1388 | DKB | Calibrators, Drug Mixture | 2 | DRI Negative Urine Calibrator | ||
20 | 00884883005891 | 963602 | MYZ | Kit,Test(Donors),For Bloodborne Pathogen | 2 | Acrometrix BB NAT HIV-1 POS. CTRL | ||
21 | 00884883005594 | 0920 | JXM | Enzyme Immunoassay, Benzodiazipine | 2 | DRI Benzodiazepine Serum Tox Assay | ||
22 | 00884883005587 | 0911 | DIS | Enzyme Immunoassay, Barbiturate | 2 | DRI Barbiturate Serum Tox Assay | ||
23 | 00884883005501 | 100282 | JQY | Ph Meter | 1 | DRI pH-Detect pH 3.6 Control Kit | ||
24 | 00884883005174 | 100255 | LAS | Drug Specific Control Materials | 1 | DRI Oxycodone 300 Controls | ||
25 | 00884883005082 | 100117 | DLJ | Calibrators, Drug Specific | 2 | DRI Methadone Metabolite 150 ng/mL Calibrator | ||
26 | 00884883004771 | 1732153 | DLJ | Calibrators, Drug Specific | 2 | CEDIA LSD Cutoff Calibrator | ||
27 | 00884883004399 | 10014182 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
28 | 00884883004382 | 10014181 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
29 | 00884883004375 | 10014180 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
30 | 00884883004368 | 10014179 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
31 | 00884883004337 | 1815296 | DJG | Enzyme Immunoassay, Opiates | 2 | CEDUA DAU Opiate 2K | ||
32 | 00884883004160 | 024227 | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | MAS Urinalysis Liquid Urinalysis Control 3 | ||
33 | 00884883004153 | 024224 | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | MAS Urinalysis Liquid Urinalysis Control 3 | ||
34 | 00884883004108 | 1661248 | DJG | Enzyme Immunoassay, Opiates | 2 | CEDIA DAU Opiate | ||
35 | 00884883003798 | CHU-SP | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MASĀ® ChemTRAK H Unassayed Control Sample Pack | ||
36 | 00884883003637 | LG-S1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
37 | 00884883003613 | CAI-XLS | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
38 | 00884883003606 | CAI-XL4 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
39 | 00884883003477 | 100248 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
40 | 00884883003415 | 0514 | KXS | Radioimmunoassay, Methaqualone | 2 | DRI Methaqualone Assay | ||
41 | 00884883003347 | 10013878 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
42 | 00884883003330 | 10013877 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
43 | 00884883003323 | 10013876 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
44 | 00884883002968 | 100249 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
45 | 00884883002937 | 0515 | KXS | Radioimmunoassay, Methaqualone | 2 | DRI Methaqualone Assay | ||
46 | 00884883002920 | 100116 | DJR | Enzyme Immunoassay, Methadone | 2 | DRI Methadone Metabolite Assay | ||
47 | 00884883002401 | LIG-303 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
48 | 00884883002395 | LIG-202 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
49 | 00884883002388 | LIG-101 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
50 | 00884883002371 | CAI-XLL | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00884883011342 | 10014681 | DRI Ecstasy Assay | MICROGENICS CORPORATION | ||
2 | 00884883011069 | 10014947 | CEDIA Amphetamine OFT Assay | MICROGENICS CORPORATION | ||
3 | 00884883006751 | 10024631 | DRI Ecstasy Plus Assay | MICROGENICS CORPORATION | ||
4 | 00884883004665 | 10014585 | DRI Amphetamines Assay | MICROGENICS CORPORATION | ||
5 | 00884883002883 | 100076 | DRI Ecstasy Assay | MICROGENICS CORPORATION | ||
6 | 00884883002821 | 0018 | DRI Amphetamines Assay | MICROGENICS CORPORATION | ||
7 | 00884883002524 | 0017 | DRI Amphetamines Assay | MICROGENICS CORPORATION | ||
8 | 00884883001350 | 100075 | DRI Ecstasy Assay | MICROGENICS CORPORATION | ||
9 | 00884883000841 | 10021729 | CEDIA Amphetamine OFT Assay | MICROGENICS CORPORATION | ||
10 | 00884883000209 | 10018579 | CEDIA Amphetamine OFT Assay | MICROGENICS CORPORATION | ||
11 | 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 |
12 | 00868586000230 | K051161 | HairCheck-DT (Amphetamines) is an ELISA test kit used for qualitative detection HairCheck-DT (Amphetamines) is an ELISA test kit used for qualitative detection of amphetamines in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls. | HairCheck-DT (Amphetamines) | QUEST DIAGNOSTICS | |
13 | 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 |
14 | 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 |
15 | 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. | |
16 | 00868348000249 | 76025AA2K | 76025AA2K | AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. 6 Panel Drug Test Cup | Status ASSURE | LIFESIGN L.L.C. |
17 | 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. |
18 | 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. |
19 | 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. |
20 | 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. |
21 | 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. |
22 | 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. | |
23 | 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. | |
24 | 00863112000364 | CI-575 | CI-575 | 7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC | BioTech Screening | BIOTECH SCREENING LLC |
25 | 00863112000326 | CINM-774 | CINM-774 | 7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC | BioTech Screening | BIOTECH SCREENING LLC |
26 | 00863112000319 | CINM-274 | CINM-274 | 7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC | BioTech Screening | BIOTECH SCREENING LLC |
27 | 00863112000302 | CI-565 | CI-565 | 6-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY | BioTech Screening | BIOTECH SCREENING LLC |
28 | 00860003196984 | MDC-254R | CLIA Waived 14 Panel Drug Test Card(THC50/COC300/OPI2000/AMP1000/MET1000) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
29 | 00860003196908 | MDC-254R | CLIA Waived 5 Panel Drug Test Card(THC50/COC300/OPI2000/AMP1000/MET1000) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
30 | 00860001731996 | MDC-254R | CLIA Waived 5 Panel Drug Test Cup (THC50/COC300/OPI2000/AMP1000/MET1000) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
31 | 00859144006313 | 30640D | 30640D | (BZO/BAR)+AMP+COC+OPI2000+THC DipCard | DrugSmart Dip | TWIN SPIRIT INC. |
32 | 00859144006306 | 30530D | 30530D | AMP/BAR/COC/OPI2000/THC Dipcard | DrugSmart Dip | TWIN SPIRIT INC. |
33 | 00859144006290 | 30520D | 30520D | AMP/BZO/COC/OPI2000/THC Dipcard | DrugSmart Dip | TWIN SPIRIT INC. |
34 | 00859144006283 | 30510D | 30510D | AMP/BAR/BZO/COC/THC DipCard | DrugSmart Dip | TWIN SPIRIT INC. |
35 | 00859144006276 | 30500D | 30500D | AMP/COC/MET1000/OPI2000/THC DipCard | DrugSmart Dip | TWIN SPIRIT INC. |
36 | 00859144006269 | 30730D | 30730D | (BZO/BAR)+(MET1000/OPI2000)+AMP+COC+THC DipCard | DrugSmart Dip | TWIN SPIRIT INC. |
37 | 00859144006245 | 30600D | 30600D | (MET1000/OPI2000)+AMP+BZO+COC+THC DipCard | DrugSmart Dip | TWIN SPIRIT INC. |
38 | 00859144006238 | 61127D | 61127D | AMP/OPI300/COC/THC/MET/BZO/BAR/MTD/OXY/MDMA/BUP drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
39 | 00859144006221 | 61230D | 61230D | THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
40 | 00859144006214 | 61093D-3C | 61093D-3C | PCP/AMP/THC/COC150/MET500/BAR/BZO/OPI300/OXY/MDMA with adulteration pH/CR/OX dru PCP/AMP/THC/COC150/MET500/BAR/BZO/OPI300/OXY/MDMA with adulteration pH/CR/OX drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
41 | 00859144006207 | 60500D | 60500D | THC/COC/AMP/MET/OPI drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
42 | 00859144006191 | 60505D | 60505D | THC/COC/AMP/PCP/OPI drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
43 | 00859144006184 | 60560D | 60560D | THC/COC/AMP/BAR/OPI drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
44 | 00859144006177 | 60600D | 60600D | THC/COC/AMP/BZO/OPI/MET drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
45 | 00859144006160 | 60620D | 60620D | THC/COC/AMP/MET/OPI/OXY drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
46 | 00859144006153 | 60960D | 60960D | THC/COC/OPI/AMP/MET/BZO/MTD/OXY/BUP drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
47 | 00859144006146 | 61015D | 61015D | COC/THC/BZO/AMP/BAR/OPI2000/MET/MDMA/TCA/PCP drugs of abuse tes cup | DrugSmart Cup | TWIN SPIRIT INC. |
48 | 00859144006139 | 61020D | 61020D | THC/COC/AMP/PCP/OPI/MET/BAR/BZO/MTD/OXY drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
49 | 00859144006115 | 61025D | 61025D | THC/COC/BAR/BZO/MET/OPI300/AMP/PPX/OXY/MDMA drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |
50 | 00859144006108 | 61050D | 61050D | THC/COC/AMP/BAR/BZO/MET/OPI300/PPX/OXY/BUP drugs of abuse test cup | DrugSmart Cup | TWIN SPIRIT INC. |