No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00628451188049 | 1009785RDB-G3 | 1009785RDB-G3 | The package contains replacement component for use only with Reveal G3 Rapid HIV The package contains replacement component for use only with Reveal G3 Rapid HIV-1 Antibody Test. The component is lot-specific. | MZF | Test, Hiv Detection | 2 | MedMira Universal Buffer |
2 | 00628451188032 | 1009785RCP-G3 | 1009785RCP-G3 | The package contains replacement component for use only with Reveal G3 Rapid HIV The package contains replacement component for use only with Reveal G3 Rapid HIV-1 Antibody Test. Components are lot-specific. | MZF | Test, Hiv Detection | 2 | MedMira Human HIV-1 Human Test Control |
3 | 00628451188087 | 815311007590 | 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. | MZF | Test, Hiv Detection | 2 | HIV-1 Antibody Test Controls | |
4 | 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. | MZF | Test, Hiv Detection | 2 | HIV-1 Antibody Test Controls | |
5 | 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. | MZF | Test, Hiv Detection | 2 | HIV-1 Antibody Test Controls | |
6 | 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. | MZF | Test, Hiv Detection | 2 | HIV-1 Antibody Test Controls | |
7 | 00628451188063 | 815311007576 | 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. | MZF | Test, Hiv Detection | 2 | Reveal G4 Rapid HIV-1 Antibody Test | |
8 | 00628451188070 | 815311000591 | 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. | MZF | Test, Hiv Detection | 2 | Reveal G4 Rapid HIV-1 Antibody Test | |
9 | 00628451188056 | 815311007583 | 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. | MZF | Test, Hiv Detection | 2 | Reveal G4 Rapid HIV-1 Antibody Test | |
10 | 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. | MZF | Test, Hiv Detection | 2 | Reveal G4 Rapid HIV-1 Antibody Test | |
11 | 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. | MZF | Test, Hiv Detection | 2 | Reveal G4 Rapid HIV-1 Antibody Test | |
12 | 00628451188018 | 815311000591 | 815311000591 | 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. | MZF | Test, Hiv Detection | 2 | Reveal G3 Rapid HIV-1 Antibody Test |
13 | 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. | MZF | Test, Hiv Detection | 2 | Reveal G3 Rapid HIV-1 Antibody Test |
14 | 00628451188094 | 815311007606 | 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. | MZF | Test, Hiv Detection | 2 | Universal Buffer |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04015630942510 | 06924115160 | 06924115160 | PreciControl HIV; HIV-2 + GrpO | ROCHE DIAGNOSTICS GMBH | |
2 | 04015630942503 | 06924107160 | 06924107160 | PreciControl HIV Gen II | ROCHE DIAGNOSTICS GMBH | |
3 | 04015630942497 | 05390095160 | 05390095160 | HIV combi PT Elecsys cobas e 100 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH |
4 | 03610522112791 | 12009911 | 12009911 | GS HIV Combo Ag/Ab EIA, 4800 Tests | GS | BIO-RAD LABORATORIES, INC. |
5 | 03610522112784 | 12009860 | 12009860 | GS HIV Combo Ag/Ab, 960 Tests | GS | BIO-RAD LABORATORIES, INC. |
6 | 03610522112777 | 12009912 | 12009912 | GS HIV Combo Ag/Ab EIA, 192 Tests | GS | BIO-RAD LABORATORIES, INC. |
7 | 03610522110414 | 12009799 | 12009799 | Conjugate 2 Diluent, GS HIV Combo Ag/Ab, 120mL | GS | BIO-RAD LABORATORIES, INC. |
8 | 03610522110209 | 12009798 | 12009798 | Conjugate 2, GS HIV Combo Ag/Ab, 12 mL | GS | BIO-RAD LABORATORIES, INC. |
9 | 03610520563939 | 4.3_v5 | 12001442 | BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
10 | 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. |
11 | 03610520519813 | SW4.2_v4 | 6653475A | BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4 | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
12 | 03610520506493 | 6633435 | 6633435 | BioPlex 2200, HIV Ag-Ab Control Set | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
13 | 03610520506486 | 6633405 | 6633405 | BioPlex 2200 HIV Ag-Ab Calibrator Set | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
14 | 03610520179871 | 12003863 | 12003863 | GS HIV Combo Ag/Ab EIA, 4800 Tests | GS | BIO-RAD LABORATORIES, INC. |
15 | 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. |
16 | 03610520013854 | 72339 | Geenius HIV 1/2 Controls | Geenius | BIO-RAD | |
17 | 03610520013847 | 72461 | 72461 | Geenius HIV 1/2 Supplemental assay | Geenius | BIO-RAD |
18 | 00884999050402 | 2.00 | 08N45-03B | Alinity m HIV-1 Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
19 | 00884999048638 | 1.00 | 08N45-03A | Alinity m HIV-1 Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
20 | 00884999048065 | 06L83-008 | 06L83-008 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM | RealTime | ABBOTT MOLECULAR INC. |
21 | 00884999047785 | 08N45-085 | 08N45-085 | Alinity m | ABBOTT MOLECULAR INC. | |
22 | 00884999047778 | 08N45-075 | 08N45-075 | Alinity m | ABBOTT MOLECULAR INC. | |
23 | 00884999047730 | 08N45-095 | 08N45-095 | Alinity m | ABBOTT MOLECULAR INC. | |
24 | 00884999042704 | 06L83-007 | 06L83-007 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM | RealTime | ABBOTT MOLECULAR INC. |
25 | 00884999037472 | 06L87-02 | 06L87-02 | Uracil-N-Glycosylase (UNG) | RealTime | ABBOTT MOLECULAR INC. |
26 | 00884999037427 | 6L18-67 | 6L18-67 | Abbott RealTime HIV-1 Amplification Extended Use Including Uracil-N-Glycosylase (UNG) | RealTime | ABBOTT MOLECULAR INC. |
27 | 00884999037304 | 6L18-50 | 6L18-50 | Abbott RealTime HIV-1 Amplification Reagent Extended Use | RealTime | ABBOTT MOLECULAR INC. |
28 | 00884999037168 | 6L83-06 | 6L83-06 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM, Version 6.0 | RealTime | ABBOTT MOLECULAR INC. |
29 | 00884999023949 | 6L18-90 | 6L18-90 | Abbott RealTime HIV-1 Amplification Reagent Kit | RealTime | ABBOTT MOLECULAR INC. |
30 | 00884999023932 | 6L18-80 | 6L18-80 | Abbott RealTime HIV-1 Control Kit | RealTime | ABBOTT MOLECULAR INC. |
31 | 00884999023925 | 6L18-70 | 6L18-70 | Abbott RealTime HIV-1 Calibrator Kit | RealTime | ABBOTT MOLECULAR INC. |
32 | 00884999023918 | 06L18-66 | 06L18-66 | Abbott RealTime HIV-1 Amplification Including Uracil-N-Glycosylase (UNG) for use Abbott RealTime HIV-1 Amplification Including Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HIV-1 assay List Number 06L18 | RealTime | ABBOTT MOLECULAR INC. |
33 | 00875197006483 | 09040536190 | 09040536190 | cobas® HIV-1/HIV- 2 192T | ROCHE MOLECULAR SYSTEMS, INC. | |
34 | 00875197006476 | 09040773190 | 09040773190 | cobas® HBV/HCV/HIV-1 Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
35 | 00875197006445 | 09051554190 | 09051554190 | cobas® NHP Negative Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
36 | 00875197006407 | 09040803190 | 09040803190 | cobas® HIV-1 | ROCHE MOLECULAR SYSTEMS, INC. | |
37 | 00875197004069 | 2 | 05923450190 | COBAS® TaqMan® HIV-1 Test version 2.0, For Use With the High Pure System | ROCHE MOLECULAR SYSTEMS, INC. | |
38 | 00875197003024 | 2 | 05212308190 | COBAS® AmpliPrep/ COBAS® TaqMan® HIV- 1 Test, version 2.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
39 | 00869978000029 | 700000 | Maxim HIV-1 Urine EIA | MAXIM BIOMEDICAL, INC. | ||
40 | 00869978000012 | 98078 | Cambridge Biotech HIV-1 Urine Western Blot | MAXIM BIOMEDICAL, INC. | ||
41 | 00847865019255 | 6653455 | 6653455 | BioPlex 2200 HIV Ag-Ab Reagent Pack | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
42 | 00847865018845 | 0210-00 | 0210-00 | Plate Sealers 25/pkg x 40pkgs | GS | BIO-RAD LABORATORIES, INC. |
43 | 00847865018487 | 6633440 | 6633440 | BioPlex 2200, HIV Ag-Ab Control Lot Data | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
44 | 00847865018470 | 6633420 | 6633420 | BioPlex 2200, HIV Ag-Ab Calibrator Lot Data | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
45 | 00847865018456 | 26166 | 26166 | MULTISPOT HIV-1/HIV-2 Rapid Test Negative Control Serum (Human) 1.0 mL | Bio-Rad | BIO-RAD LABORATORIES, INC. |
46 | 00847865013253 | 26228 | 26228 | GS HIV Combo Ag/Ab EIA, Conjugate 2 Diluent, 40 mL | GS | BIO-RAD LABORATORIES, INC. |
47 | 00847865013246 | 26227 | 26227 | GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 40 mL | GS | BIO-RAD LABORATORIES, INC. |
48 | 00847865013239 | 26226 | 26226 | GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 18 mL | GS | BIO-RAD LABORATORIES, INC. |
49 | 00847865013222 | 26225 | 26225 | GS HIV Combo Ag/Ab EIA, Conjugate 1, 10 mL | GS | BIO-RAD LABORATORIES, INC. |
50 | 00847865013215 | 26224 | 26224 | GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL | GS | BIO-RAD LABORATORIES, INC. |