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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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 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
NEEDLE ADAPTER, TOOMEY TO LUER
Microaire Surgical Instruments LLC
ASP-ADP-3
In Commercial Distribution

  • 00847399006431 ()


  • Collection syringe adaptor, single-use
SYRINGE ADAPTER, TOOMEY TO LUER
Microaire Surgical Instruments LLC
ASP-ADP-2
In Commercial Distribution

  • 00847399006424 ()


  • Collection syringe adaptor, single-use
IntraSpin System 220V, Procedure Pack
BIOHORIZONS IMPLANT SYSTEMS, INC
LPRF220
In Commercial Distribution

  • 00847236016043 ()


  • Haematological concentrate system
IntraSpin System 110V, Procedure Pack
BIOHORIZONS IMPLANT SYSTEMS, INC
LPRF110
In Commercial Distribution

  • 00847236016036 ()


  • Haematological concentrate system
Xpression Box
BIOHORIZONS IMPLANT SYSTEMS, INC
CTRZ
In Commercial Distribution

  • 00847236015978 ()
  • 00847236019822 ()


  • Haematological concentrate system
IntraSpin Rotor, 110v & 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BROTORZ
In Commercial Distribution

  • 00847236015886 ()


  • Centrifuge rotor, ultracentrifuge
IntraSpin Power Cord, 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BPOWER220Z
In Commercial Distribution

  • 00847236015879 ()


  • Electrical mains power cable
IntraSpin Power Cord, 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BPOWER110Z
In Commercial Distribution

  • 00847236015862 ()


  • Electrical mains power cable
IntraSpin Hex Key, 110v & 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BHEXZ
In Commercial Distribution

  • 00847236015855 ()


  • Haematological concentrate system
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