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 | MAS® 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 | 10869419000240 | DOA-154-181 | Express ResultsTM | QUEST DIAGNOSTICS | ||
2 | 10869419000233 | UDOA-12CE-0712-01 | Express ResultsTM | QUEST DIAGNOSTICS | ||
3 | 10869419000226 | UDOA-10CE-1307-01 | Express ResultsTM | QUEST DIAGNOSTICS | ||
4 | 10869419000219 | UDOA-10CA-0503-01 | Express ResultsTM | QUEST DIAGNOSTICS | ||
5 | 10869419000202 | UDOA-6CA-0503-01 | Express ResultsTM | QUEST DIAGNOSTICS | ||
6 | 10868401000244 | RC12KC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
7 | 10868401000237 | RC05AC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
8 | 10868401000220 | RC10KC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
9 | 10868401000213 | RC05ACA | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
10 | 10868401000206 | RC05AF | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
11 | 10867802000280 | eCup | 201 | The eScreen eCup® is a patented urine collection device designed to allow for ra The eScreen eCup® is a patented urine collection device designed to allow for rapid, under-seal screening. The eCup’s lid contains several embedded reagent test strips that are sensitive to the five-test SAMHSA (Substance Abuse and Mental Health Services Administration) profile cutoff levels. The lid’s test strips also detect and provide adulteration panels for pH, creatinine, and nitrites. When the eCup is placed into the eReader device, its test strips are digitally screened for the presence or absence of drugs of abuse. | eScreen eCup | ESCREEN, INC. |
12 | 10867802000273 | DUE-1117X-071-01 | DUE-1117X-071-01 | The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is int The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test device cannot be read visually and must be used with the xReaderTM. The xCupTM qualitatively detects drug classes in human urine at the following cut-off 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 xCupTM may consist of any combination of the listed drug analytes. The xCupTM only provides a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. | xCupTM | ESCREEN, INC. |
13 | 10867802000266 | MCP5A-001 | mCup® | ESCREEN, INC. | ||
14 | 10867802000259 | MCP11A-001 | mCup® | ESCREEN, INC. | ||
15 | 10867802000242 | MCP10A-001 | mCup® | ESCREEN, INC. | ||
16 | 10867802000235 | MCP9A-001 | mCup® | ESCREEN, INC. | ||
17 | 10867802000228 | MCP7A-001 | mCup® | ESCREEN, INC. | ||
18 | 10867802000211 | MCP5-001 | mCup® | ESCREEN, INC. | ||
19 | 10866415000328 | STDIPOP-25 | STDIPOP-25 | Speedy Tests DOA Single Test Dipcard, 25Pcs/BoxOPI | Speedy Tests | SPEEDY SOLUTIONS LLC |
20 | 10864040000348 | DOA-12C | Qtest 12 (25 pack) - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD Qtest 12 (25 pack) - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50 | QTEST 12 (25 Pack) | MEDIMPEX UNITED, INC | |
21 | 10864040000331 | DOA-11Ca | Qtest 11 (25 Pack) - AMP 1000, BAR 300, BZD 300, COC 300, OPI 2000, MAD 300, MET Qtest 11 (25 Pack) - AMP 1000, BAR 300, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50 | QTEST 11 (25 pack) | MEDIMPEX UNITED, INC | |
22 | 10864040000324 | DOA-7QT | Qtest 7 (25 Pack) - AMP 1000, BZD 300, COC 300, MET 1000, OPI 2000, OXY 100, THC 50 | QTEST 7 (25 Pack) | MEDIMPEX UNITED, INC | |
23 | 10864040000317 | QT-CUP | Qtest 5 (25 pack) - AMP 1000, COC 300, MET 1000, OPI 2000,THC 50 | QTEST 5 (25 Pack) | MEDIMPEX UNITED, INC | |
24 | 10863451000428 | 1.0 | Individual 10-panel drug test cassette | Quick Test | QUICKCO, LTD | |
25 | 10858945006840 | I-DOA-167-1111 | I-DOA-167-1111 | A rapid, one step screening test for the simultaneous, qualitative detection of A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine. | iCup® | INSTANT TECHNOLOGIES, INC. |
26 | 10858945006826 | I-DUD-177-461 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
27 | 10858945006819 | I-DUE-197-261 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
28 | 10858945006802 | KC990 | AlereTM Tox Screen | INSTANT TECHNOLOGIES, INC. | ||
29 | 10858945006796 | KC840A | AlereTM Tox Screen | INSTANT TECHNOLOGIES, INC. | ||
30 | 10858945006789 | I-DOA-1195 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
31 | 10858945006772 | I-DOA-11105 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
32 | 10858945006765 | I-DOA-1185 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
33 | 10858945006758 | I-DOA-3155 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
34 | 10858945006741 | I-DOA-2155 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
35 | 10858945006734 | I-DOA-1165 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
36 | 10858945006727 | I-DOA-1155 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
37 | 10858945006710 | I-DOA-1145 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
38 | 10858945006697 | I-DOP-102 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
39 | 10858945006680 | I-DOX-102 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
40 | 10858945006628 | I-DCB-1115-011 | AlereTM iCassette® Dx | INSTANT TECHNOLOGIES, INC. | ||
41 | 10858945006611 | I-DOA-364 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
42 | 10858945006604 | IS6B | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
43 | 10858945006598 | IS2MT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
44 | 10858945006574 | IS1MOP | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
45 | 10858945006567 | IS1OPI | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
46 | 10858945006529 | IS9 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
47 | 10858945006512 | IS5MB | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
48 | 10858945006505 | IS5M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
49 | 10858945006499 | IS5A | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
50 | 10858945006482 | IS4M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. |