MedMira Laboratories Inc

Address:155 Chain Lake Drive,Halifax Nova Scotia,CA

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Device Description : 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.

Device Class : 2

Duns Number: 243757049

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : 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.

Device Class : 2

Duns Number: 243757049

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : 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.

Device Class : 2

Duns Number: 243757049

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : 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.

Device Class : 2

Duns Number: 243757049

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : 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.

Device Class : 2

Duns Number: 243757049

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1