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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 - 00628451188179

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

Trima Accel® - 05020583810013

Automated Blood Collection System
TERUMO BCT, INC.
81001
In Commercial Distribution

  • 05020583810013 ()


  • Apheresis system

COBE® Spectra - 05020583706200

White Blood Cell Set- Functionally Closed
TERUMO BCT, INC.
70620
In Commercial Distribution

  • 05020583706200 ()
  • 35020583706201 ()


  • Blood transfer set

TSCD®-II - 05020583620032

Weld Integrity Test Kit for TSCD®II Sterile Tubing Welder
TERUMO BCT, INC.
62003
In Commercial Distribution

  • 05020583620032 ()


  • Package sealing unit

SCD®-IIB - 05020583620025

SCD®-IIB Sterile Tubing Welder
TERUMO BCT, INC.
62002
In Commercial Distribution

  • 05020583620025 ()


  • Package sealing unit

Trucise® 2.0 Total System - 05020583300088

Trucise 2.0 Communication Module
TERUMO BCT, INC.
METCM2
In Commercial Distribution

  • 05020583300088 ()


  • Blood bank information system

TSCD®-II - 05020583300064

3-Ncc947 Weld Integrity Test Kit
TERUMO BCT, INC.
3NCC947
In Commercial Distribution

  • 05020583300064 ()


  • Package sealing unit

TSCD® - 05020583300040

Weld Integrity Test Kit
TERUMO BCT, INC.
3NCC945
In Commercial Distribution

  • 05020583300040 ()


  • Package sealing unit

TSCD® II - 05020583300033

Sterile Tubing Welder
TERUMO BCT, INC.
3MESC203A
In Commercial Distribution

  • 05020583300033 ()


  • Package sealing unit

SCD® IIB - 05020583300026

SCD II Final Assembly
TERUMO BCT, INC.
3NCC986
In Commercial Distribution

  • 05020583300026 ()


  • Package sealing unit
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