No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00380740200053 | 08P433C | 08P433C | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
2 | 00380740200060 | 09P271B | 09P271B | Alinity i Anti-CCP Assay File | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Alinity |
3 | 00380740200046 | 08P435C | 08P435C | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
4 | 00380740200039 | 08P431C | 08P431C | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
5 | 00380740200022 | 08P437C | 08P437C | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
6 | 00380740199487 | 04V511B | 04V511B | Alinity c Total Bilirubin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
7 | 00380740195458 | 07P701C | 07P701C | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
8 | 00380740195380 | 08P181B | 08P181B | Alinity c A-ALT Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
9 | 00380740194208 | 09P523B | 09P523B | Alinity c BenzSQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
10 | 00380740194192 | 09P521B | 09P521B | Alinity c BenzQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
11 | 00380740194093 | 06S611A | 06S611A | Alinity i COV 2IgGII Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
12 | 00380740193638 | 04Z211A | 04Z211A | Alinity i STAT High Sensitivity Tropopnin-I | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
13 | 00380740193577 | 07P701B | 07P701B | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
14 | 00380740192723 | 04U093A | 04U093A | Alinity c Uric2-U Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
15 | 00380740192464 | 06R911A | 06R911A | Alinity i COV-2 IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
16 | 00380740189105 | 08P013B | 08P013B | Alinity c CrEnzU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
17 | 00380740189099 | 08P011B | 08P011B | Alinity c CrEnz Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
18 | 00380740186418 | 04T843A | 04T843A | Alinity c ALT2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
19 | 00380740186401 | 04T841A | 04T841A | Alinity c ALT2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
20 | 00380740186395 | 04T863A | 04T863A | Alinity c AST2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
21 | 00380740186388 | 04T861A | 04T861A | Alinity c AST2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
22 | 00380740186364 | 04U091A | 04U091A | Alinity c Uric2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
23 | 00380740186265 | 04T961A | 04T961A | Alinity c GGT2 Asasy File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
24 | 00380740186159 | 04T811A | 04T811A | Alinity c TPRO2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
25 | 00380740185978 | 07P569A | 07P569A | Alinity c CardiacCRP Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
26 | 00380740185787 | 09P261B | 09P261B | Alinity i Active B12 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
27 | 00380740181000 | 09P533A | 09P533A | Alinity c SerBENZQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
28 | 00380740180201 | 08P433B | 08P433B | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
29 | 00380740180195 | 08P435B | 08P435B | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
30 | 00380740180188 | 08P431B | 08P431B | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
31 | 00380740180171 | 08P437B | 08P437B | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
32 | 00380740180164 | 08P541B | 08P541B | Alinity c Phenytoin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
33 | 00380740180157 | 08P591B | 08P591B | Alinity c Salicylate Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
34 | 00380740180140 | 08P193C | 08P193C | Alinity c MagnesiumU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
35 | 00380740180133 | 08P191C | 08P191C | Alinity c Magnesium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
36 | 00380740180126 | 09P631B | 09P631B | Alinity c IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
37 | 00380740180119 | 08P531D | 08P531D | Alinity c Lithium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
38 | 00380740180089 | 08P041B | 08P041B | Alinity c Microalb Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
39 | 00380740180058 | 08P551B | 08P551B | Alinity c Gentamicin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
40 | 00380740180041 | 09P931B | 09P931B | Alinity c Cerulo Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
41 | 00380740180034 | 07P591B | 07P591B | Alinity c U/CSF Prot Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
42 | 00380740180027 | 07P751B | 07P751B | Alinity c Ultra HDL Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
43 | 00380740180010 | 07P771B | 07P771B | Alinity c Trig Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
44 | 00380740180003 | 09P861B | 09P861B | Alinity c Prealbumin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
45 | 00380740179991 | 07P761B | 07P761B | Alinity c Chol Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
46 | 00380740179984 | 08P021B | 08P021B | Alinity c AlbuminBCG Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
47 | 00380740179977 | 07P691C | 07P691C | Alinity i Free T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
48 | 00380740179960 | 07P941C | 07P941C | Alinity i Total T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
49 | 00380740179571 | 07P567A | 07P567A | Alinity c CRP WR Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
50 | 00380740179564 | 07P565A | 07P565A | Alinity c CRP HS Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 15420045504240 | SPECIMEN DIL, VIRAL ASSAY, APTIMA, IVD | PRD-03503 | N/A | APTIMA | HOLOGIC, INC. |
2 | 15420045504233 | HIV VIRAL ASSAY, CNTRLS, APTIMA, US IVD | PRD-03567 | N/A | APTIMA | HOLOGIC, INC. |
3 | 15420045504226 | HIV VIRAL ASSAY CAL, APTIMA, US IVD | PRD-03566 | APTIMA | HOLOGIC, INC. | |
4 | 15420045504219 | HIV VIRAL ASSAY, APTIMA, 100T, US IVD | PRD-03565 | APTIMA | HOLOGIC, INC. | |
5 | 10758750031597 | 6842782 | 6842782 | VITROS Immunodiagnostic Products HIV Combo Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
6 | 10758750031580 | 6842781 | 6842781 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
7 | 10758750001538 | 6801862 | 6801862 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
8 | 10758750001521 | 6801861 | 6801861 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
9 | 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 | |
10 | 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 | |
11 | 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 | |
12 | 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 | |
13 | 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 | |
14 | 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 | |
15 | 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 |
16 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | Elecsys HIV Duo | ROCHE DIAGNOSTICS GMBH |
17 | 07613336170212 | 08924180160 | 08924180160 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH | |
18 | 07613336170182 | 08924163160 | 08924163160 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH | |
19 | 07613336166949 | 08836973190 | 08836973190 | Elecsys HIV Duo | ROCHE DIAGNOSTICS GMBH | |
20 | 06865979010313 | 90-1031 | 90-1031 | INSTI HIV-1/HIV-2 Control Test | INSTI HIV-1/HIV-2 Control Test | BIOLYTICAL LABORATORIES INC |
21 | 06865979010306 | 90-1030 | 90-1030 | HIV-1 Control Test Kit | HIV-1 Control Test Kit | BIOLYTICAL LABORATORIES INC |
22 | 06865979010207 | Without Support | 90-1020 | 24 tests without support material | INSTI HIV-1/HIV-2 Antibody Test | BIOLYTICAL LABORATORIES INC |
23 | 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 |
24 | 06865979010184 | With Support | 90-1018 | 24 Tests with support materials | INSTI HIV-1/HIV-2 Antibody Test | BIOLYTICAL LABORATORIES INC |
25 | 06865978010710 | 80-1071 | 80-1071 | INSTI Test Controls HIV-1 | INSTI Test Controls HIV-1 | BIOLYTICAL LABORATORIES INC |
26 | 06865978010376 | 80-1037 | 80-1037 | INSTI HIV-1/HIV-2 Test Controls | INSTI HIV-1/HIV-2 Test Controls | BIOLYTICAL LABORATORIES INC |
27 | 05391516746113 | 1206530 | 1206530 | Uni-Gold™ Recombigen® HIV Controls | Uni-Gold™ | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
28 | 05391516746106 | 1206506 | 1206506 | Uni-Gold™ Recombigen® HIV-1/2 | Uni-Gold™ | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
29 | 04015630942510 | 06924115160 | 06924115160 | PreciControl HIV; HIV-2 + GrpO | ROCHE DIAGNOSTICS GMBH | |
30 | 04015630942503 | 06924107160 | 06924107160 | PreciControl HIV Gen II | ROCHE DIAGNOSTICS GMBH | |
31 | 04015630942497 | 05390095160 | 05390095160 | HIV combi PT Elecsys cobas e 100 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH |
32 | 03610522112791 | 12009911 | 12009911 | GS HIV Combo Ag/Ab EIA, 4800 Tests | GS | BIO-RAD LABORATORIES, INC. |
33 | 03610522112784 | 12009860 | 12009860 | GS HIV Combo Ag/Ab, 960 Tests | GS | BIO-RAD LABORATORIES, INC. |
34 | 03610522112777 | 12009912 | 12009912 | GS HIV Combo Ag/Ab EIA, 192 Tests | GS | BIO-RAD LABORATORIES, INC. |
35 | 03610522110414 | 12009799 | 12009799 | Conjugate 2 Diluent, GS HIV Combo Ag/Ab, 120mL | GS | BIO-RAD LABORATORIES, INC. |
36 | 03610522110209 | 12009798 | 12009798 | Conjugate 2, GS HIV Combo Ag/Ab, 12 mL | GS | BIO-RAD LABORATORIES, INC. |
37 | 03610520563939 | 4.3_v5 | 12001442 | BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
38 | 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. |
39 | 03610520519813 | SW4.2_v4 | 6653475A | BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4 | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
40 | 03610520506493 | 6633435 | 6633435 | BioPlex 2200, HIV Ag-Ab Control Set | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
41 | 03610520506486 | 6633405 | 6633405 | BioPlex 2200 HIV Ag-Ab Calibrator Set | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
42 | 03610520179871 | 12003863 | 12003863 | GS HIV Combo Ag/Ab EIA, 4800 Tests | GS | BIO-RAD LABORATORIES, INC. |
43 | 03610520178904 | SW4.3_v5 | 12003844 | U.S. IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, SW 4.3_v5 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
44 | 03610520013854 | 72339 | Geenius HIV 1/2 Controls | Geenius | BIO-RAD | |
45 | 03610520013847 | 72461 | 72461 | Geenius HIV 1/2 Supplemental assay | Geenius | BIO-RAD |
46 | 00884999050402 | 2.00 | 08N45-03B | Alinity m HIV-1 Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
47 | 00884999048638 | 1.00 | 08N45-03A | Alinity m HIV-1 Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
48 | 00884999048065 | 06L83-008 | 06L83-008 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM | RealTime | ABBOTT MOLECULAR INC. |
49 | 00884999047785 | 08N45-085 | 08N45-085 | Alinity m | ABBOTT MOLECULAR INC. | |
50 | 00884999047778 | 08N45-075 | 08N45-075 | Alinity m | ABBOTT MOLECULAR INC. |