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Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) 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 and/or HIV-2. 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.
MedMira Laboratories Inc
815311007552
In Commercial Distribution
- 10628451188220 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007545
In Commercial Distribution
- 10628451188213 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal® G4 Rapid HIV-1/2 Antibody Test (Reveal® G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) 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 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapids tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815211007507
In Commercial Distribution
- 10628451188169 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
Bio-Rad Medical Diagnostics GmbH
12010902
In Commercial Distribution
- 03610522136421 ()
12010902
- Laboratory instrument/analyser application software IVD
IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution
- 03610522123919 ()
12010236
- Laboratory instrument/analyser application software IVD
IH-Com Kit Fullversion US; Software Version: 04.0.27.
Bio-Rad Medical Diagnostics GmbH
04.0.27
In Commercial Distribution
- 03610520569870 ()
009100
- Laboratory instrument/analyser application software IVD
Geenius HIV 1/2 Controls
BIO-RAD
72339
In Commercial Distribution
- 03610520013854 ()
- HIV1/HIV2 antibody IVD, control
Geenius HIV 1/2 Supplemental assay
BIO-RAD
72461
In Commercial Distribution
- 03610520013847 ()
72461
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
Bio-Rad Medical Diagnostics GmbH
12008722
In Commercial Distribution
- 03610522055685 ()
12008722
- Column agglutination IVD
No Description
Regenlab USA LLC
RK-THT-3
Not in Commercial Distribution
- 08500331310073 ()
- Haematological concentrate system preparation kit, platelet concentration