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SCD II Final Assembly
TERUMO BCT, INC.
3NCC986
In Commercial Distribution
- 05020583300026 ()
- Package sealing unit
TOMEs Terumo Operational Medical Equipment Software Version 7.3
TERUMO BCT, INC.
11401
In Commercial Distribution
- 05020583114012 ()
11401
- Blood bank information system application software
IDL Set
TERUMO BCT, INC.
10300
In Commercial Distribution
- 05020583103009 ()
- 35020583103000 ()
- Blood transfer set
Collection Set
TERUMO BCT, INC.
10110
In Commercial Distribution
- 05020583101104 ()
- 35020583101105 ()
- Blood transfer set
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
815311007590
In Commercial Distribution
- 00628451188209 ()
- 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 rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311000591
In Commercial Distribution
- 00628451188193 ()
- 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 rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007576
In Commercial Distribution
- 00628451188186 ()
- 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
815311007583
In Commercial Distribution
- 00628451188179 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
LIPOFILTER - CLINICAL PACK WITHOUT SYRINGE
Microaire Surgical Instruments LLC
ASP-CAN-NT
In Commercial Distribution
- 00847399017352 ()
- Liposuction system
LIPOFILTER - CLINICAL PACK
Microaire Surgical Instruments LLC
ASP-CAN-2S
In Commercial Distribution
- 00847399015884 ()
- Liposuction system