Other products from "ORTHO CLINICAL DIAGNOSTICS"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10758750034895 6177750 6177750 VITROS Immunodiagnostic ProductsAFP Calibrators JIS Calibrator, primary 2 VITROS
2 10758750034819 6177745 6177745 VITROS Immunodiagnostic Products AFP Reagent Pack LOJ KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER 2 VITROS
3 10758750034659 6199330 6199330 VITROS Immunodiagnostic ProductsProlactin Calibrators JIS Calibrator, primary 2 VITROS
4 10758750034420 6199961 6199961 VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator QKO Reagent, coronavirus serological VITROS
5 10758750034413 6199960 6199960 VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack QKO Reagent, coronavirus serological VITROS
6 10758750034321 6199337 6199337 VITROS Immunodiagnostic Products Prolactin Reagent Pack CFT RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) 1 VITROS
7 10758750034314 6199336 6199336 VITROS Immunodiagnostic Products CK-MB Reagent Pack JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES 2 VITROS
8 10758750033409 6199924 6199924 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls QKO Reagent, coronavirus serological VITROS
9 10758750033393 6199923 6199923 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator QKO Reagent, coronavirus serological VITROS
10 10758750033386 6199922 6199922 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack QKO Reagent, coronavirus serological VITROS
11 10758750033379 6199921 6199921 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls QKO Reagent, coronavirus serological VITROS
12 10758750033362 6199920 6199920 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator QKO Reagent, coronavirus serological VITROS
13 10758750033355 6199919 6199919 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack QKO Reagent, coronavirus serological VITROS
14 10758750033317 6192256 6192256 VITROS Immunodiagnostic Products NT-proBNP II Calibrators JIT Calibrator, secondary 2 VITROS
15 10758750033300 6192255 6192255 VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack NBC Test, natriuretic peptide 2 VITROS
16 10758750033294 6195575 6195575 VITROS Immunodiagnostic Products BRAHMS PCT Calibrator PMT Device to detect and measure procalcitonin (PCT) in human clinical specimens 2 VITROS
17 10758750033287 6197735 6197735 VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack PMT Device to detect and measure procalcitonin (PCT) in human clinical specimens 2 VITROS
18 10758750033195 691 2265 691 2265 VITROS Immunodiagnostic Products HIV Combo Controls (Anti-HIV-1 group O) OHQ Multi-analyte controls unassayed 1 VITROS
19 10758750033171 691 2263 691 2263 VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen) OHQ Multi-analyte controls unassayed 1 VITROS
20 10758750033164 691 2261 691 2261 VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) OHQ Multi-analyte controls unassayed 1 VITROS
21 10758750032945 6905561 6905561 VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers PMT Device to detect and measure procalcitonin (PCT) in human clinical specimens 2 VITROS
22 10758750032938 6905560 6905560 VITROS Immunodiagnostic Products BRAHMS PCT Controls PMT Device to detect and measure procalcitonin (PCT) in human clinical specimens 2 VITROS
23 10758750032068 6844425 6844425 VITROS Immunodiagnostic Products Insulin Reagent Pack CFP RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN 1 VITROS
24 10758750032051 6844424 6844424 VITROS Immunodiagnostic Products C-peptide Calibrators JIT Calibrator, secondary 2 VITROS
25 10758750032044 6844426 6844426 VITROS Immunodiagnostic Products Insulin Calibrators JIT Calibrator, secondary 2 VITROS
26 10758750032037 6844423 6844423 VITROS Immunodiagnostic Products C-peptide Reagent Pack JKD RADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN 1 VITROS
27 10758750031580 6842781 6842781 VITROS Immunodiagnostic Products HIV Combo Reagent Pack MZF Test, hiv detection 2 VITROS
28 10758750030217 6844056 6844056 VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack MRG SYSTEM, TEST, VITAMIN D 2 VITROS
29 10758750030200 6844055 6844055 VITROS Immunodiagnostic Products25-OH Vitamin D Total Calibrators JIT CALIBRATOR, SECONDARY 2 VITROS
30 10758750009541 1681543 1681543 VITROS Immunodiagnostic Products Cortisol Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
31 10758750009411 1619360 1619360 VITROS Immunodiagnostic Products Anemia Controls JJY Multi-analyte controls, all kinds (assayed) 1 VITROS
32 10758750009404 1614965 1614965 VITROS Immunodiagnostic Products Total T3 Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
33 10758750009367 1540525 1540525 VITROS Immunodiagnostic Products Vitamin B12 Calibrators CDD RADIOASSAY, VITAMIN B12 2 VITROS
34 10758750009237 1513266 1513266 VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 CGN ACID, FOLIC, RADIOIMMUNOASSAY 2 VITROS
35 10758750009213 1487289 1487289 VITROS Immunodiagnostic Products TSH Calibrators JIT CALIBRATOR, SECONDARY 2 VITROS
36 10758750009145 1471481 1471481 VITROS Immunodiagnostic Products T3 Uptake Reagent Pack KHQ RADIOASSAY, TRIIODOTHYRONINE UPTAKE 2 VITROS
37 10758750009138 1453489 1453489 VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 CDD RADIOASSAY, VITAMIN B12 2 VITROS
38 10758750009077 1435205 1435205 VITROS Immunodiagnostic Products Testosterone Reagent Pack CDZ RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE 1 VITROS
39 10758750009053 1420025 1420025 VITROS Immunodiagnostic Products Metabolism Controls JJX Single (specified) analyte controls (assayed and unassayed) 1 VITROS
40 10758750009015 1410646 1410646 VITROS Immunodiagnostic Products Total Thyroid Controls JJY Multi-analyte controls, all kinds (assayed) 1 VITROS
41 10758750008995 1393396 1393396 VITROS Immunodiagnostic Products Total T4 Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
42 10758750008971 1387000 1387000 VITROS Immunodiagnostic Products Free T4 Reagent Pack CEC RADIOIMMUNOASSAY, FREE THYROXINE 2 VITROS
43 10758750008926 1372101 1372101 VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator LOL Hepatitis a test (antibody and igm antibody) 2 VITROS
44 10758750008902 1350198 1350198 VITROS Immunodiagnostic Products LH Reagent Pack CEP RADIOIMMUNOASSAY, LUTEINIZING HORMONE 1 VITROS
45 10758750008834 1322528 1322528 VITROS Immunodiagnostic Products Total T3 Reagent Pack CDP RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE 2 VITROS
46 10758750008810 1318930 1318930 VITROS Immunodiagnostic ProductsEstradiol Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
47 10758750008803 1315654 1315654 VITROS Immunodiagnostic Products Free Thyroid Controls JJY Multi-analyte controls, all kinds (assayed) 1 VITROS
48 10758750008797 1315589 1315589 VITROS Immunodiagnostic Products Free T3 Reagent Pack CDP RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE 2 VITROS
49 10758750008766 1311075 1311075 VITROS Immunodiagnostic Products Folate Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
50 10758750008742 1306026 1306026 VITROS Immunodiagnostic ProductsTestosterone Calibrators JIX CALIBRATOR, MULTI-ANALYTE MIXTURE 2 VITROS
Other products with the same Product Code "MZF"
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