No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00847865013178 | 26203 | 26203 | Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
2 | 00847865013161 | 26202 | 26202 | Anti-HBc IgM EIA, Conjugate, Lyophilized, 7.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
3 | 00847865013154 | 26201 | 26201 | Anti-HBc IgM EIA, Negative Control, 0.8 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
4 | 00847865013147 | 26200 | 26200 | Anti-HBc IgM EIA, Positive Control,1.6 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
5 | 00847865013130 | 26199 | 26199 | Anti-HBc IgM EIA, Specimen Diluent, 30 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
6 | 00847865013123 | 26198 | 26198 | Anti-HBc IgM EIA Conjugate Diluent, 30 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
7 | 00847865013116 | 26197 | 26197 | Anti-HBc EIA, Negative Control, 0.8 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
8 | 00847865013109 | 26196 | 26196 | Anti-HBc EIA, Specimen Diluent, 30 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
9 | 00847865013093 | 26195 | 26195 | Anti-HBc EIA, Cutoff Calibrator, 1.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
10 | 00847865013086 | 26194 | 26194 | Anti-HBc EIA, Positive Control, 0.8 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
11 | 00847865013079 | 26193 | 26193 | Anti-HBc EIA, Conjugate Reagent 30 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
12 | 00847865011372 | 26186 | 26186 | MONOLISA™ Anti-HBc EIA 192 Tests | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
13 | 00847865011365 | 26174 | 26174 | MONOLISA™ Anti-HBc IgM EIA, 192 Tests | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
14 | 00847865002110 | 26156 | 26156 | Anti-HBs EIA, Specimen Diluent 10 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
15 | 00847865002103 | 26155 | 26155 | Anti-HBs EIA, Conjugate Diluent 15 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
16 | 00847865002097 | 26154 | 26154 | Anti-HBs EIA, 10 mIU/mL Calibrator 1.8 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
17 | 00847865002080 | 26153 | 26153 | Anti-HBs EIA, Negative Control 1.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
18 | 00847865002073 | 26152 | 26152 | Anti-HBs EIA, Positive Control 1.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
19 | 00847865002066 | 26151 | 26151 | Anti-HBs EIA Hepatitis B Surface Antigen (Human) Horeseradish Peroxidase Conjugate | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
20 | 00847865002042 | 25219 | 25219 | MONOLISA™ Anti-HBs EIA Calibrator Kit | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
21 | 00847865001687 | 31996 | 31996 | Kallestad Patient Sample Diluent | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
22 | 00847865001670 | 26106 | 26106 | Kallestad HEp-2 Cell Line 24 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
23 | 00847865001779 | 30480 | 30480 | Kallestad FITC Conjugate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
24 | 00847865001762 | 30446 | 30446 | Kallestad FITC Conjugate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
25 | 00847865001755 | 30431 | 30431 | Kallestad Evans' Blue Counterstain | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
26 | 00847865001724 | 26115 | 26115 | Kallestad Mouse Stomach/Kidney 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
27 | 00847865001717 | 26112 | 26112 | Kallestad Mouse Stomach/Kidney 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
28 | 00847865001700 | 26111 | 26111 | Kallestad Mouse Stomach/Kidney 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
29 | 00847865001694 | 30443 | 30443 | Kallestad Mouse Stomach Kidney Substrate | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
30 | 00847865001656 | 26104 | 26104 | Kallestad HEp-2 Cell Line 12 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
31 | 00847865001649 | 26103 | 26103 | Kallestad HEp-2 Cell Line 12 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
32 | 00847865001632 | 26102 | 26102 | Kallestad HEp-2 Cell Line 12 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
33 | 00847865001625 | 26101 | 26101 | Kallestad HEp-2 Cell Line 6 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
34 | 00847865001618 | 26100 | 26100 | Kallestad HEp-2 Cell Line 6 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
35 | 00847865001601 | 30472 | 30472 | Kallestad HEp-2 Cell Line Substrate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
36 | 00847865001595 | 30471 | 30471 | Kallestad HEp-2 Cell Line Substrate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
37 | 00847865001588 | 32583 | 32583 | Kallestad HEp-2 Cell Line Substrate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
38 | 00847865001571 | 26110 | 26110 | Kallestad Crithidia luciliae 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
39 | 00847865001564 | 26109 | 26109 | Kallestad Crithidia luciliae 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
40 | 00847865001557 | 26108 | 26108 | Kallestad Crithidia luciliae 4 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
41 | 00847865001540 | 26107 | 26107 | Kallestad Crithidia luciliae 4 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
42 | 00847865001533 | 31069 | 31069 | Kallestad Crithidia luciliae Substrate | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
43 | 00847865001526 | 30404 | 30404 | Kallestad Crithidia luciliae Substrate | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
44 | 00847865001496 | 32514 | 32514 | MONOFLUO Legionella pneumophila IFA Test Kit | LHL | REAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT | 2 | Kallestad |
45 | 00847865001205 | 30403 | 30403 | Kallestad Mounting Media | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
46 | 00847865019347 | 12000667 | 12000667 | Slide Blotters, 8-well | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
47 | 00847865019354 | 12000668 | 12000668 | Slide Blotters, 24-well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
48 | 00847865019330 | 12000666 | 12000666 | Slide Blotters, 4-well | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
49 | 00847865017343 | 12000660 | 12000660 | Slide Blotters, 6-well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
50 | 00847865017244 | 12000661 | 12000661 | Slide Blotters, 12-well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00686597010310 | 90-1031 | 90-1031 | INSTI HIV-1/HIV-2 Control Test Kit | INSTI HIV-1/HIV-2 Control Test Kit | BIOLYTICAL LABORATORIES INC |
2 | 00686597010303 | 90-1030 | 90-1030 | INSTI HIV-1 Control Test Kit | INSTI HIV-1 Control Test Kit | BIOLYTICAL LABORATORIES INC |
3 | 00686597010198 | 90-1019 | 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 |
4 | 00630414600390 | 10995459 | 10995459 | CHIV - Atellica IM - RGT - 100T | Atellica IM CHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00630414599342 | 10995611 | 10995611 | HIV 1/O/2 (eHIV) - Atellica IM - RGT - 200T | Atellica IM EHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00630414598550 | 10995528 | 10995528 | CHIV QC Kit Atellica IM - CLT 5 x 1 x 15.0mL | Atellica IM CHIV QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00630414590202 | 10697214 | 10697214 | ADVIA Centaur® CHIV Quality Control Material | ADVIA Centaur® CHIV QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
8 | 00630414589749 | 10696880 | 10696880 | ADVIA Centaur® CHIV assay (100 tests) | ADVIA Centaur® CHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00630414511245 | 10332613 | 1622429 | HIV 1/O/2 Enhanced (EHIV) (1-pack) 200T Assay Kit | ADVIA Centaur® EHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00630414509372 | 10309010 | 1324827 | HIV 1/O/2 Enhanced (EHIV) Quality Control Material Kit | ADVIA Centaur® Systems EHIV QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00630414457611 | 10335367 | 127418B | HIV RNA 3.0 Assay (bDNA) US IVD (Box 2) | VERSANT® HIV-1 RNA 3.0 Assay bDNA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
12 | 00630414457604 | 10335480 | 127418A | HIV RNA 3.0 Assay (bDNA) US IVD (Box 1) | VERSANT® HIV-1 RNA 3.0 Assay bDNA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
13 | 00630414301280 | 11207266 | 11207266 | CHIV - Atellica IM - RGT - 100T | Atellica IM CHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
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. | Universal Buffer | MEDMIRA LABORATORIES INC | |
15 | 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. | HIV-1 Antibody Test Controls | MEDMIRA LABORATORIES INC | |
16 | 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. | Reveal G4 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC | |
17 | 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. | Reveal G4 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC | |
18 | 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. | Reveal G4 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC | |
19 | 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. | MedMira Universal Buffer | MEDMIRA LABORATORIES INC |
20 | 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. | MedMira Human HIV-1 Human Test Control | MEDMIRA LABORATORIES INC |
21 | 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. | Reveal G3 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC |
22 | 00608337103403 | 1001-0340 | OraQuick In Home HIV Test | ORASURE TECHNOLOGIES, INC. | ||
23 | 00608337001334 | 1001-0528 | OraQuick In Home HIV Test, Pharmacy | ORASURE TECHNOLOGIES, INC. | ||
24 | 00608337000962 | 1001-0374 | OraQuick In Home HIV Test (Not for Resale) | ORASURE TECHNOLOGIES, INC. | ||
25 | 00607158000083 | 65-9502-0 | The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection. | DPP HIV-Syphilis | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
26 | 00607158000076 | 60-9549-0 | The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for u The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio HIV 1/2 STAT-PAK® Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. | Chembio HIV Reactive/Nonreactive Controls | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
27 | 00607158000069 | 60-9507-0 | The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Chembio SURE CHECK® HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 Copies of Subject Information Notice. | Chembio SURE CHECK HIV 1/2 Assay | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
28 | 00607158000052 | 60-9505-1 | The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test f The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK® assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of HIV Running Buffer, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice. | Chembio HIV 1/2 Stat-Pak Assay | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
29 | 00607158000045 | 60-9552-0 | The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for u The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control) as described. One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.5mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. | Chembio DPP HIV 1/2 Rapid Test Control Pack | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
30 | 00607158000038 | 60-9546-0 | The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents fo The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Assay only. Clearview® HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. | Clearview HIV Reactive/Nonreactive Controls | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
31 | 00607158000021 | 60-9523-0 | The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice. | Clearview Complete HIV 1/2 | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
32 | 00607158000007 | 65-9500-0 | The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for th The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice. | Chembio DPP HIV 1/2 Assay | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
33 | 00380740146252 | 08P0702 | 08P0702 | Alinity i HIV Ag/Ab Combo Calibrator | Alinity | ABBOTT GMBH |
34 | 00380740136574 | 08P0712 | 08P0712 | Alinity i HIV Ag/Ab Combo Controls | Alinity | ABBOTT GMBH |
35 | 00380740121778 | 08P0731 | 08P0731 | Alinity i HIV Ag/Ab Combo Reagent Kit 1200 Tests | Alinity | ABBOTT GMBH |
36 | 00380740121754 | 08P0721 | 08P0721 | Alinity i HIV Ag/Ab Combo Reagent Kit 200 Tests | Alinity | ABBOTT GMBH |
37 | 00380740003906 | 2P36-35 | 02P3635 | ARCHITECT HIV Ag/Ab Combo Reagent Kit | ARCHITECT | ABBOTT GMBH |
38 | 00380740003890 | 2P36-25 | 02P3625 | ARCHITECT HIV Ag/Ab Combo Reagent Kit | ARCHITECT | ABBOTT GMBH |
39 | 00380740003883 | 2P36-10 | 02P3610 | ARCHITECT HIV Ag/Ab Combo Controls | ARCHITECT | ABBOTT GMBH |
40 | 00380740003876 | 2P36-01 | 02P3601 | ARCHITECT HIV Ag/Ab Combo Calibrator | ARCHITECT | ABBOTT GMBH |
41 | 15420045504240 | SPECIMEN DIL, VIRAL ASSAY, APTIMA, IVD | PRD-03503 | N/A | APTIMA | HOLOGIC, INC. |
42 | 15420045504233 | HIV VIRAL ASSAY, CNTRLS, APTIMA, US IVD | PRD-03567 | N/A | APTIMA | HOLOGIC, INC. |
43 | 15420045504226 | HIV VIRAL ASSAY CAL, APTIMA, US IVD | PRD-03566 | APTIMA | HOLOGIC, INC. | |
44 | 15420045504219 | HIV VIRAL ASSAY, APTIMA, 100T, US IVD | PRD-03565 | APTIMA | HOLOGIC, INC. | |
45 | 10758750031597 | 6842782 | 6842782 | VITROS Immunodiagnostic Products HIV Combo Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
46 | 10758750031580 | 6842781 | 6842781 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
47 | 10758750001538 | 6801862 | 6801862 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
48 | 10758750001521 | 6801861 | 6801861 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
49 | 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 | |
50 | 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 |