Other products from "CHEMBIO DIAGNOSTIC SYSTEMS INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00607158000113 70-1064-0 70-1064-0 The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectanc The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectance reader configured to read exclusive results of the DPP Zika IgM test cartridge, through the application of an RFID tag applied to one side of the reader, which carries the DPP Zika test configuration. Once configured, the reader measures the intensity of the control and analyte lines on the test device, and shows the test results on the LCD display. The DPP Micro Reader minimizes human errors due to subjective visual interpretation; therefore, the operator cannot visually interpret the results of DPP Assay Devices made to be read with a DPP Micro Reader; they must be read exclusively with the DPP Micro Reader. JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 1 DPP Zika IgM Micro Reader
2 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. MZF Test, Hiv Detection 2 Chembio HIV 1/2 Stat-Pak Assay
3 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. MZF Test, Hiv Detection 2 Chembio HIV Reactive/Nonreactive Controls
4 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. MZF Test, Hiv Detection 2 Clearview HIV Reactive/Nonreactive Controls
5 00607158000106 65-9560-0 The DPP Zika IgM System is intended for the presumptive qualitative detection of The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). QFO Zika Virus Serological Reagents 2 DPP Zika IgM System
6 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. MZF Test, Hiv Detection 2 Chembio SURE CHECK HIV 1/2 Assay
7 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. MZF,LIP Test, Hiv Detection,Enzyme Linked Immunoabsorption Assay, Treponema Pallidum 2 DPP HIV-Syphilis
8 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. MZF Test, Hiv Detection 2 Chembio DPP HIV 1/2 Assay
9 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. MZF Test, Hiv Detection 2 Clearview Complete HIV 1/2
Other products with the same Product Code "MZF"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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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
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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
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