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 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. MZF Test, Hiv Detection 2 Chembio DPP HIV 1/2 Rapid Test Control Pack
5 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
6 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
7 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
8 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
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
1 00847865019255 6653455 6653455 BioPlex 2200 HIV Ag-Ab Reagent Pack BioPlex® 2200 BIO-RAD LABORATORIES, INC.
2 00847865018845 0210-00 0210-00 Plate Sealers 25/pkg x 40pkgs GS BIO-RAD LABORATORIES, INC.
3 00847865018487 6633440 6633440 BioPlex 2200, HIV Ag-Ab Control Lot Data BioPlex® 2200 BIO-RAD LABORATORIES, INC.
4 00847865018470 6633420 6633420 BioPlex 2200, HIV Ag-Ab Calibrator Lot Data BioPlex® 2200 BIO-RAD LABORATORIES, INC.
5 00847865018456 26166 26166 MULTISPOT HIV-1/HIV-2 Rapid Test Negative Control Serum (Human) 1.0 mL Bio-Rad BIO-RAD LABORATORIES, INC.
6 00847865013253 26228 26228 GS HIV Combo Ag/Ab EIA, Conjugate 2 Diluent, 40 mL GS BIO-RAD LABORATORIES, INC.
7 00847865013246 26227 26227 GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 40 mL GS BIO-RAD LABORATORIES, INC.
8 00847865013239 26226 26226 GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 18 mL GS BIO-RAD LABORATORIES, INC.
9 00847865013222 26225 26225 GS HIV Combo Ag/Ab EIA, Conjugate 1, 10 mL GS BIO-RAD LABORATORIES, INC.
10 00847865013215 26224 26224 GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL GS BIO-RAD LABORATORIES, INC.
11 00847865013208 26222 26222 GS HIV Combo Ag/Ab EIA, HIV-2/O Ab Pos Ctrl, 1.5 mL GS BIO-RAD LABORATORIES, INC.
12 00847865013192 26221 26221 GS HIV Combo Ag/Ab EIA, HIV-1 Ab Pos Ctrl, 1.5 mL GS BIO-RAD LABORATORIES, INC.
13 00847865013185 26220 26220 GS HIV Combo Ag/Ab EIA, Negative Control, 1.5 mL GS BIO-RAD LABORATORIES, INC.
14 00847865011563 32536 32536 Human Immunodeficiency Virus Type 2, GS HIV-2 EIA, 480-Test Kit GS BIO-RAD LABORATORIES, INC.
15 00847865011105 6600306 6600306 BioPlex® 2200 Manual Reagent Pack Piercer BioPlex® 2200 BIO-RAD LABORATORIES, INC.
16 00847865010672 26223 26223 GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL GS BIO-RAD LABORATORIES, INC.
17 00847865010665 26218 26218 GS HIV Combo Ag/Ab EIA, 960 Tests GS BIO-RAD LABORATORIES, INC.
18 00847865010658 26217 26217 GS HIV Combo Ag/Ab EIA, 192 Tests GS BIO-RAD LABORATORIES, INC.
19 00847865002745 25228 25228 MULTISPOT HIV-1/HIV-2 Rapid Test 50 Tests Bio-Rad BIO-RAD LABORATORIES, INC.
20 00847865002028 25123 25123 HIV-1/HIV-2 PLUS O EIA Specimen Diluent, 100 mL GS BIO-RAD LABORATORIES, INC.
21 00847865002011 25122 25122 HIV-1/HIV-2 PLUS O EIA Conjugate Concentrate, 12 mL GS BIO-RAD LABORATORIES, INC.
22 00847865002004 25121 25121 HIV-1/HIV-2 PLUS O EIA Conjugate Diluent, 120 mL GS BIO-RAD LABORATORIES, INC.
23 00847865001991 25120 25120 HIV-1/HIV-2 PLUS O EIA HIV-1 Group O Positive Control, 1.4 mL GS BIO-RAD LABORATORIES, INC.
24 00847865001984 25119 25119 HIV-1/HIV-2 PLUS O EIA HIV-2 Positive Control, 1.4 mL GS BIO-RAD LABORATORIES, INC.
25 00847865001977 25118 25118 HIV-1/HIV-2 PLUS O EIA HIV-1 Positive Control, 1.4 mL GS BIO-RAD LABORATORIES, INC.
26 00847865001960 25117 25117 HIV-1/HIV-2 PLUS O EIA HIV Negative Control, 8 mL GS BIO-RAD LABORATORIES, INC.
27 00847865001953 25256 25256 Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PLUS O EIA 4800 Test Kit GS BIO-RAD LABORATORIES, INC.
28 00847865001946 32589 32589 Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) G Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PLUS O EIA 960 Test Kit GS BIO-RAD LABORATORIES, INC.
29 00847865001939 32588 32588 Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) G Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PLUS O EIA 480 Test Kit GS BIO-RAD LABORATORIES, INC.
30 00847865001816 26182 26182 Chromogen:TMB Solution 1:11 12 mL Bio-Rad BIO-RAD LABORATORIES, INC.
31 00847865001809 26181 26181 Substrate Buffer TMB buf., 120 mL Bio-Rad BIO-RAD LABORATORIES, INC.
32 00847865001793 25260 25260 STOP Stopping Solution 1N 15 x 120 mL Bio-Rad BIO-RAD LABORATORIES, INC.
33 00847865001786 25261 25261 Wash Solution Concentrate (30X), 15 x 120 mL Bio-Rad BIO-RAD LABORATORIES, INC.
34 00847865001281 SW4.2_v4 665-3465A U.S. IFU Manual and CDs, BioPlex 2200 HIV Ag-Ab IFU 665-3465A BioPlex® 2200 BIO-RAD LABORATORIES, INC.
35 00686597010310 90-1031 90-1031 INSTI HIV-1/HIV-2 Control Test Kit INSTI HIV-1/HIV-2 Control Test Kit BIOLYTICAL LABORATORIES INC
36 00686597010303 90-1030 90-1030 INSTI HIV-1 Control Test Kit INSTI HIV-1 Control Test Kit BIOLYTICAL LABORATORIES INC
37 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
38 00630414600390 10995459 10995459 CHIV - Atellica IM - RGT - 100T Atellica IM CHIV SIEMENS HEALTHCARE DIAGNOSTICS INC.
39 00630414599342 10995611 10995611 HIV 1/O/2 (eHIV) - Atellica IM - RGT - 200T Atellica IM EHIV SIEMENS HEALTHCARE DIAGNOSTICS INC.
40 00630414598550 10995528 10995528 CHIV QC Kit Atellica IM - CLT 5 x 1 x 15.0mL Atellica IM CHIV QC SIEMENS HEALTHCARE DIAGNOSTICS INC.
41 00630414590202 10697214 10697214 ADVIA Centaur® CHIV Quality Control Material ADVIA Centaur® CHIV QC SIEMENS HEALTHCARE DIAGNOSTICS INC.
42 00630414589749 10696880 10696880 ADVIA Centaur® CHIV assay (100 tests) ADVIA Centaur® CHIV SIEMENS HEALTHCARE DIAGNOSTICS INC.
43 00630414511245 10332613 1622429 HIV 1/O/2 Enhanced (EHIV) (1-pack) 200T Assay Kit ADVIA Centaur® EHIV SIEMENS HEALTHCARE DIAGNOSTICS INC.
44 00630414509372 10309010 1324827 HIV 1/O/2 Enhanced (EHIV) Quality Control Material Kit ADVIA Centaur® Systems EHIV QC SIEMENS HEALTHCARE DIAGNOSTICS INC.
45 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.
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48 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
49 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
50 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