| Primary Device ID | 00607158000038 |
| NIH Device Record Key | fbb98da2-9d55-4085-b496-e22b6efeabda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clearview HIV Reactive/Nonreactive Controls |
| Version Model Number | 60-9546-0 |
| Company DUNS | 160348470 |
| Company Name | Chembio Diagnostic Systems Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
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| 00607158000083 - DPP HIV-Syphilis | 2021-01-06 The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immun |
| 00607158000106 - DPP Zika IgM System | 2020-08-14 The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain |
| 00607158000007 - Chembio DPP HIV 1/2 Assay | 2018-07-06 The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodefici |
| 00607158000021 - Clearview Complete HIV 1/2 | 2018-07-06 The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immun |
| 00607158000038 - Clearview HIV Reactive/Nonreactive Controls | 2018-07-06The 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. |
| 00607158000038 - Clearview HIV Reactive/Nonreactive Controls | 2018-07-06 The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Ass |
| 00607158000045 - Chembio DPP HIV 1/2 Rapid Test Control Pack | 2018-07-06 The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chem |
| 00607158000052 - Chembio HIV 1/2 Stat-Pak Assay | 2018-07-06 The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunod |