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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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Unimed - 06945664802451

Reusable SpO2 Sensor/百特/Soft Tip/Adult/3.0M/045
Unimed Medical Supplies, Inc.
U410S-12
In Commercial Distribution

  • 06945664802451 ()


  • Pulse oximeter probe, reusable

BioPlex 2200 - 00847865000758

MMRV IgG Control Lot Data
BIO-RAD LABORATORIES, INC.
6632440
In Commercial Distribution

  • 00847865000758 ()

  • 1 Each
6632440

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
  • Measles virus immunoglobulin G (IgG) antibody IVD, control
  • Rubella virus immunoglobulin G (IgG) antibody IVD, control
  • Mumps virus immunoglobulin G (IgG) antibody IVD, control

BioPlex 2200 - 00847865000741

MMRV IgG Control Set
BIO-RAD LABORATORIES, INC.
6632430
In Commercial Distribution

  • 00847865000741 ()

  • Total Volume: 1.5 Milliliter
  • 4 Vials
6632430

  • Measles virus immunoglobulin G (IgG) antibody IVD, control
  • Rubella virus immunoglobulin G (IgG) antibody IVD, control
  • Mumps virus immunoglobulin G (IgG) antibody IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control

ACCURUN® - 00816784020178

ACCURUN 40 Series 5000 Anti- Measles, Mumps, Rubella, VZV 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0039
In Commercial Distribution

  • 00816784020178 ()
2000-0039

  • Mumps virus immunoglobulin G (IgG) antibody IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
  • Measles virus immunoglobulin G (IgG) antibody IVD, control
  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

AtheNA Multi-Lyte® MMRV IgG Plus Test System - 00845533000062

The ZEUS AtheNA Multi-Lyte® MMRV IgG Plus Test System is intended for the qualitative presumptive detection of IgG class antibody to Measles (Rubeola), Mumps, Rubella and Varicella-Zoster (VZ) viruses in human serum using the AtheNA Multi-Lyte® System. The test is intended to be used for determination of a previous infection with the Measles, Mumps, VZ viruses and to determine the serological status of individuals including women of childbearing age. This test has been calibrated to the WHO International Standard for Rubella IgG at the cut-off. The magnitude of the test result above or below the cut-off does not correspond to International Units and is not indicative of total amount of antibody present. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, infants or children. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A93101G
In Commercial Distribution

  • 00845533000062 ()
A93101G

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010979

MMRV IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010979 ()

  • 1 Each
6652470D

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002332

U.S. Only IFU, Manual & CDs, MMRV IgG IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW 4.1V1
In Commercial Distribution

  • 00847865002332 ()

  • 1 Each
6652465G

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002264

MMRV IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002264 ()

  • 1 Each
6652470C

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865000765

MMRV IgG Reagent Pack
BIO-RAD LABORATORIES, INC.
6652450
In Commercial Distribution

  • 00847865000765 ()

  • 100 Tests
6652450

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865000734

MMRV IgG Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6632420
In Commercial Distribution

  • 00847865000734 ()

  • 1 Each
6632420

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, calibrator
  • Mumps virus immunoglobulin G (IgG) antibody IVD, calibrator
  • Measles virus immunoglobulin G (IgG) antibody IVD, calibrator
  • Rubella virus immunoglobulin G (IgG) antibody IVD, calibrator
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