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 | 00608337001297 | 1001-0336 | Histofreezer, US Sample, 5M1C | GEH | Unit, Cryosurgical, Accessories | Histofreezer | ||
32 | 00608337000733 | 1154IC | LCM | Enzyme Immunoassay, Phencyclidine | U | PCP Intercept 100 Plate Kit | ||
33 | 00608337000559 | 1001-0375 | Histofreezer Kit, U.S., 60MC2 +10 | GEH | Unit, Cryosurgical, Accessories | 2 | Histofreezer | |
34 | 00608337000399 | 1124EB | MKU | Enzyme Immunoassasy, Nocotine And Nicotine Metabolites | 1 | Cotinine Serum 5 Plate Kit | ||
35 | 00608337000276 | 1118IC | LDJ | Enzyme Immunoassay, Cannabinoids | 2 | Cannabinoids Intercept 100 Plate Kit | ||
36 | 00608337000269 | 1118IB | LDJ | Enzyme Immunoassay, Cannabinoids | 2 | Cannabinoids Intercept 5 Plate Kit | ||
37 | 00608337000238 | 1110IB | JXM | Enzyme Immunoassay, Benzodiazepine | 2 | Benzodiazepine 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 | 00380740146252 | 08P0702 | 08P0702 | Alinity i HIV Ag/Ab Combo Calibrator | Alinity | ABBOTT GMBH |
2 | 00380740136574 | 08P0712 | 08P0712 | Alinity i HIV Ag/Ab Combo Controls | Alinity | ABBOTT GMBH |
3 | 00380740121778 | 08P0731 | 08P0731 | Alinity i HIV Ag/Ab Combo Reagent Kit 1200 Tests | Alinity | ABBOTT GMBH |
4 | 00380740121754 | 08P0721 | 08P0721 | Alinity i HIV Ag/Ab Combo Reagent Kit 200 Tests | Alinity | ABBOTT GMBH |
5 | 00380740003906 | 2P36-35 | 02P3635 | ARCHITECT HIV Ag/Ab Combo Reagent Kit | ARCHITECT | ABBOTT GMBH |
6 | 00380740003890 | 2P36-25 | 02P3625 | ARCHITECT HIV Ag/Ab Combo Reagent Kit | ARCHITECT | ABBOTT GMBH |
7 | 00380740003883 | 2P36-10 | 02P3610 | ARCHITECT HIV Ag/Ab Combo Controls | ARCHITECT | ABBOTT GMBH |
8 | 00380740003876 | 2P36-01 | 02P3601 | ARCHITECT HIV Ag/Ab Combo Calibrator | ARCHITECT | ABBOTT GMBH |
9 | 15420045504240 | SPECIMEN DIL, VIRAL ASSAY, APTIMA, IVD | PRD-03503 | N/A | APTIMA | HOLOGIC, INC. |
10 | 15420045504233 | HIV VIRAL ASSAY, CNTRLS, APTIMA, US IVD | PRD-03567 | N/A | APTIMA | HOLOGIC, INC. |
11 | 15420045504226 | HIV VIRAL ASSAY CAL, APTIMA, US IVD | PRD-03566 | APTIMA | HOLOGIC, INC. | |
12 | 15420045504219 | HIV VIRAL ASSAY, APTIMA, 100T, US IVD | PRD-03565 | APTIMA | HOLOGIC, INC. | |
13 | 10758750031597 | 6842782 | 6842782 | VITROS Immunodiagnostic Products HIV Combo Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
14 | 10758750031580 | 6842781 | 6842781 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
15 | 10758750001538 | 6801862 | 6801862 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
16 | 10758750001521 | 6801861 | 6801861 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
17 | 10628451188152 | 815311007514 | HIV-1 Antibody Test Controls (Test Controls) are external quality control agents HIV-1 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. | HIV-1 Antibody Test Controls | MEDMIRA LABORATORIES INC | |
18 | 10628451188145 | 815311007521 | HIV-1 Antibody Test Controls (Test Controls) are external quality control agents HIV-1 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. | HIV-1 Antibody Test Controls | MEDMIRA LABORATORIES INC | |
19 | 10628451188138 | 815311007538 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve im Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms. | Reveal G4 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC | |
20 | 10628451188121 | 815311007569 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve im Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms. | Reveal G4 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC | |
21 | 10628451188114 | 815311007552 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve im Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms. | Reveal G4 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC | |
22 | 10628451188107 | 815311007545 | HIV-1 Antibody Test Controls (Test Controls) are external quality control agents HIV-1 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. | HIV-1 Antibody Test Controls | MEDMIRA LABORATORIES INC | |
23 | 10628451188022 | 815311007569 | 815311007569 | Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human serum or plasma. The Reveal G3 Rapid HIV-1 Antibody Test is intended for use as a point-of-care test to aid in diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms. | Reveal G3 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC |
24 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | Elecsys HIV Duo | ROCHE DIAGNOSTICS GMBH |
25 | 07613336170212 | 08924180160 | 08924180160 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH | |
26 | 07613336170182 | 08924163160 | 08924163160 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH | |
27 | 07613336166949 | 08836973190 | 08836973190 | Elecsys HIV Duo | ROCHE DIAGNOSTICS GMBH | |
28 | 06865979010313 | 90-1031 | 90-1031 | INSTI HIV-1/HIV-2 Control Test | INSTI HIV-1/HIV-2 Control Test | BIOLYTICAL LABORATORIES INC |
29 | 06865979010306 | 90-1030 | 90-1030 | HIV-1 Control Test Kit | HIV-1 Control Test Kit | BIOLYTICAL LABORATORIES INC |
30 | 06865979010207 | Without Support | 90-1020 | 24 tests without support material | INSTI HIV-1/HIV-2 Antibody Test | BIOLYTICAL LABORATORIES INC |
31 | 06865979010191 | Single | 90-1019 | Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2) | INSTI HIV-1/HIV-2 Antibody Test | BIOLYTICAL LABORATORIES INC |
32 | 06865979010184 | With Support | 90-1018 | 24 Tests with support materials | INSTI HIV-1/HIV-2 Antibody Test | BIOLYTICAL LABORATORIES INC |
33 | 06865978010710 | 80-1071 | 80-1071 | INSTI Test Controls HIV-1 | INSTI Test Controls HIV-1 | BIOLYTICAL LABORATORIES INC |
34 | 06865978010376 | 80-1037 | 80-1037 | INSTI HIV-1/HIV-2 Test Controls | INSTI HIV-1/HIV-2 Test Controls | BIOLYTICAL LABORATORIES INC |
35 | 05391516746113 | 1206530 | 1206530 | Uni-Gold™ Recombigen® HIV Controls | Uni-Gold™ | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
36 | 05391516746106 | 1206506 | 1206506 | Uni-Gold™ Recombigen® HIV-1/2 | Uni-Gold™ | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
37 | 04015630942510 | 06924115160 | 06924115160 | PreciControl HIV; HIV-2 + GrpO | ROCHE DIAGNOSTICS GMBH | |
38 | 04015630942503 | 06924107160 | 06924107160 | PreciControl HIV Gen II | ROCHE DIAGNOSTICS GMBH | |
39 | 04015630942497 | 05390095160 | 05390095160 | HIV combi PT Elecsys cobas e 100 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH |
40 | 03610522112791 | 12009911 | 12009911 | GS HIV Combo Ag/Ab EIA, 4800 Tests | GS | BIO-RAD LABORATORIES, INC. |
41 | 03610522112784 | 12009860 | 12009860 | GS HIV Combo Ag/Ab, 960 Tests | GS | BIO-RAD LABORATORIES, INC. |
42 | 03610522112777 | 12009912 | 12009912 | GS HIV Combo Ag/Ab EIA, 192 Tests | GS | BIO-RAD LABORATORIES, INC. |
43 | 03610522110414 | 12009799 | 12009799 | Conjugate 2 Diluent, GS HIV Combo Ag/Ab, 120mL | GS | BIO-RAD LABORATORIES, INC. |
44 | 03610522110209 | 12009798 | 12009798 | Conjugate 2, GS HIV Combo Ag/Ab, 12 mL | GS | BIO-RAD LABORATORIES, INC. |
45 | 03610520563939 | 4.3_v5 | 12001442 | BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
46 | 03610520563922 | 4.3_v5 | 12001443 | U.S.IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, US, SW4.3_v5 12001443 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
47 | 03610520519813 | SW4.2_v4 | 6653475A | BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4 | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
48 | 03610520506493 | 6633435 | 6633435 | BioPlex 2200, HIV Ag-Ab Control Set | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
49 | 03610520506486 | 6633405 | 6633405 | BioPlex 2200 HIV Ag-Ab Calibrator Set | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
50 | 03610520179871 | 12003863 | 12003863 | GS HIV Combo Ag/Ab EIA, 4800 Tests | GS | BIO-RAD LABORATORIES, INC. |