No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00608337103403 | 1001-0340 | MZF | Test, Hiv Detection | OraQuick In Home HIV Test | |||
2 | 00608337001426 | 3001-2940 | QID | Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens | 2 | OraQuick Ebola Rapid Antigen Test | ||
3 | 00608337000412 | 1122SB | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | Cocaine OraSure 5 Plate Kit | ||
4 | 00608337000344 | 1142IT | DJR | Enzyme Immunoassay, Methadone | 2 | Methadone Intercept 2 Plate Kit | ||
5 | 00608337000337 | 1142IC | DJR | Enzyme Immunoassay, Methadone | 2 | Methadone Intercept 100 Plate Kit | ||
6 | 00608337000283 | 1118IT | LDJ | Enzyme Immunoassay, Cannabinoids | 2 | Cannabinoids Intercept 2 Plate Kit | ||
7 | 00608337000245 | 1110IC | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | Benzodiazepine Intercept 100 Plate Kit | ||
8 | 00608337000191 | 1104IC | LAF | Gas Chromatography, Methamphetamine | 2 | Methamphetamine Intercept 100 Plate Kit | ||
9 | 00608337000917 | 3001-2661 | NNK | Container, Specimen Mailer And Storage, Non-Sterile | Intercept i2 Oral Fluid Collection Device | |||
10 | 00608337000863 | 501-0000 | MVZ | System,Test,Home,Hiv-1 | 3 | OraSure HIV-1 Western Blot Kit | ||
11 | 00608337000214 | 1108IC | DIS | Enzyme Immunoassay, Barbiturate | 2 | Barbiturates Intercept 100 Plate Kit | ||
12 | 00608337000184 | 1104IB | LAF | Gas Chromatography, Methamphetamine | 2 | Methamphetamine Intercept 5 Plate Kit | ||
13 | 00608337000153 | 1103IC | DKZ | Enzyme Immunoassay, Amphetamine | 2 | Amphetamine Intercept 100 Plate Kit | ||
14 | 00608337000665 | 1124SB | MKU | Enzyme Immunoassasy, Nocotine And Nicotine Metabolites | 1 | Cotinine OraSure 5 Plate Kit | ||
15 | 00608337000740 | 1154IT | LCM | Enzyme Immunoassay, Phencyclidine | U | PCP Intercept 2 Plate Kit | ||
16 | 00608337000689 | 1150EB | DJG | Enzyme Immunoassay, Opiates | 2 | Opiates Serum 5 plate Kit | ||
17 | 00608337000535 | 3001-1521 | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | OraQuick HCV Rapid Antibody Test | |||
18 | 00608337000054 | 1001-0323 | OraSure QuickFlu Positive and Negative Control Kit | |||||
19 | 00608337000023 | 1104IT | LAF | Gas Chromatography, Methamphetamine | 2 | Methamphetamine Intercept 2 Plate Kit | ||
20 | 00608337000672 | 1124SC | MKU | Enzyme Immunoassasy, Nocotine And Nicotine Metabolites | 1 | Cotinine OraSure 100 Plate Kit | ||
21 | 00608337000719 | 1150IC | DJG | Enzyme Immunoassay, Opiates | 2 | Opiates Intercept 100 Plate Kit | ||
22 | 00608337000702 | 1150IB | DJG | Enzyme Immunoassay, Opiates | 2 | Opiates Intercept 5 Plate Kit | ||
23 | 00608337000474 | 1224UL | 1224UL | Auto-Lyte Cotinine Urine 100mL | MKU | Enzyme Immunoassasy, Nocotine And Nicotine Metabolites | 1 | Auto-Lyte |
24 | 00608337000108 | HIV-1 Oral Specimen Collection Device | MVZ | System,Test,Home,Hiv-1 | OraSure HIV-1 Oral Specimen Collection Device | |||
25 | 00608337000085 | 1224UM | 1224UM | Auto-Lyte Cotinine Urine 1000mL | MKU | Enzyme Immunoassasy, Nocotine And Nicotine Metabolites | 1 | Auto-Lyte |
26 | 20608337000065 | 1001-0320 | GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 | OraSure Quick Flu 22-Count Flu A + B Kit | ||
27 | 00608337402100 | 1001-0293 | Histofreezer Kit, U.S., 40T1C | GEH | Unit, Cryosurgical, Accessories | 2 | Histofreezer | |
28 | 00608337365108 | 1001-0294 | Histofreezer, Kit, U.S., 36F1C | GEH | Unit, Cryosurgical, Accessories | 2 | Histofreezer | |
29 | 00608337360103 | 1001-0295 | Histofreezer Kit, U.S., 36M1C | GEH | Unit, Cryosurgical, Accessories | 2 | Histofreezer | |
30 | 00608337150308 | 60156 | DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | Q.E.D. Saliva Alcohol Test A150 | |||
31 | 00608337001334 | 1001-0528 | MZF | Test, Hiv Detection | 2 | OraQuick In Home HIV Test, Pharmacy | ||
32 | 00608337001297 | 1001-0336 | Histofreezer, US Sample, 5M1C | GEH | Unit, Cryosurgical, Accessories | Histofreezer | ||
33 | 00608337000733 | 1154IC | LCM | Enzyme Immunoassay, Phencyclidine | U | PCP Intercept 100 Plate Kit | ||
34 | 00608337000559 | 1001-0375 | Histofreezer Kit, U.S., 60MC2 +10 | GEH | Unit, Cryosurgical, Accessories | 2 | Histofreezer | |
35 | 00608337000399 | 1124EB | MKU | Enzyme Immunoassasy, Nocotine And Nicotine Metabolites | 1 | Cotinine Serum 5 Plate Kit | ||
36 | 00608337000276 | 1118IC | LDJ | Enzyme Immunoassay, Cannabinoids | 2 | Cannabinoids Intercept 100 Plate Kit | ||
37 | 00608337000269 | 1118IB | LDJ | Enzyme Immunoassay, Cannabinoids | 2 | Cannabinoids Intercept 5 Plate Kit | ||
38 | 00608337000115 | 3001-2870 | PJD | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device | OraSure Oral Fluid Collection Device | |||
39 | 00608337000047 | 1001-0321 | GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 | OraSure Quickflu Nasopharyngeal Wash / Aspirate | ||
40 | 00608337000016 | 3001-1197 | MTL | Monitor,Test,Hiv-1 | OraQuick Advance Rapid HIV 1/2 Antibody Test | |||
41 | 00608337000542 | 1001-0182 | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | OraQuick HCV Rapid Antibody Test Kit Controls | ||
42 | 00608337000429 | 1122SC | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | Cocaine OraSure 100 Plate Kit | ||
43 | 00608337000320 | 1142IB | DJR | Enzyme Immunoassay, Methadone | 2 | Methadone Intercept 5 Plate Kit | ||
44 | 00608337000962 | 1001-0374 | MZF | Test, Hiv Detection | 2 | OraQuick In Home HIV Test (Not for Resale) | ||
45 | 00608337000726 | 1154IB | LCM | Enzyme Immunoassay, Phencyclidine | U | PCP Intercept 5 Plate Kit | ||
46 | 00608337000696 | 1150ET | DJG | Enzyme Immunoassay, Opiates | 2 | Opiates Serum 2 Plate Kit | ||
47 | 00608337000405 | 1124ET | MKU | Enzyme Immunoassasy, Nocotine And Nicotine Metabolites | 1 | Cotinine Serum 2 Plate Kit | ||
48 | 00608337000313 | 1122IT | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | Cocaine Intercept 2 Plate Kit | ||
49 | 00608337000306 | 1122IC | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | Cocaine Intercept 100 Plate Kit | ||
50 | 00608337000290 | 1122IB | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | Cocaine Intercept 5 Plate Kit |
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 | 10868401000244 | RC12KC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
6 | 10868401000237 | RC05AC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
7 | 10868401000220 | RC10KC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
8 | 10868401000213 | RC05ACA | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
9 | 10868401000206 | RC05AF | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
10 | 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. |
11 | 10867802000259 | MCP11A-001 | mCup® | ESCREEN, INC. | ||
12 | 10867802000242 | MCP10A-001 | mCup® | ESCREEN, INC. | ||
13 | 10867802000235 | MCP9A-001 | mCup® | ESCREEN, INC. | ||
14 | 10867802000228 | MCP7A-001 | mCup® | ESCREEN, INC. | ||
15 | 10866415000335 | STDIP3104 | STDIP3104 | Speedy Tests DOA 10 in 1 Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC | Speedy Tests | SPEEDY SOLUTIONS LLC |
16 | 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 | |
17 | 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 | |
18 | 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 | |
19 | 10863451000428 | 1.0 | Individual 10-panel drug test cassette | Quick Test | QUICKCO, LTD | |
20 | 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. |
21 | 10858945006826 | I-DUD-177-461 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
22 | 10858945006819 | I-DUE-197-261 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
23 | 10858945006673 | I-DBZ-102 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
24 | 10858945006628 | I-DCB-1115-011 | AlereTM iCassette® Dx | INSTANT TECHNOLOGIES, INC. | ||
25 | 10858945006611 | I-DOA-364 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
26 | 10858945006604 | IS6B | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
27 | 10858945006598 | IS2MT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
28 | 10858945006529 | IS9 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
29 | 10858945006512 | IS5MB | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
30 | 10858945006505 | IS5M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
31 | 10858945006499 | IS5A | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
32 | 10858945006482 | IS4M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
33 | 10858945006475 | IS4A | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
34 | 10858945006468 | IS3OCT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
35 | 10858945006451 | IS3MCT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
36 | 10858945006444 | IS2CT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
37 | 10858945006437 | IS10 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
38 | 10858945006390 | IS1BZO | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
39 | 10858945006383 | IS8 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
40 | 10858945006376 | IS6MAP | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
41 | 10858945006369 | IS5MP | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
42 | 10858945006352 | I-DOA-194-191 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
43 | 10858945006345 | I-DUE-164-161 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
44 | 10858945006338 | I-DUE-197-221 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
45 | 10858945006321 | I-DUE-1107-291 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
46 | 10858945006314 | I-DUE-167-012 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
47 | 10858945006307 | I-DUE-167-342 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
48 | 10858945006291 | I-DUD-187-013 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
49 | 10858945006284 | I-DUE-1107-141 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
50 | 10858945006277 | I-DUD-1107-012 | iCup® | INSTANT TECHNOLOGIES, INC. |