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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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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
MMRV IgG Calibrator Set
BIO-RAD LABORATORIES, INC.
6632400
In Commercial Distribution

  • 00847865000727 ()

  • Total Volume: 0.5 Milliliter
  • 3 Vials
6632400

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, calibrator
  • Measles virus immunoglobulin G (IgG) antibody IVD, calibrator
  • Rubella virus immunoglobulin G (IgG) antibody IVD, calibrator
  • Mumps virus immunoglobulin G (IgG) antibody IVD, calibrator
The ZEUS AtheNA Multi-Lyte® MMV IgG Plus Test System is intended for the qualitative presumptive detection of IgG class antibody to Measles (Rubeola), Mumps, 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. 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.
A93111G
In Commercial Distribution

  • 00845533000079 ()
A93111G

  • Varicella-zoster virus (VZV) 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
U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_1
In Commercial Distribution

  • 00847865011075 ()

  • 1 Each
6651665E

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
ToRC IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010948 ()

  • 1 Each
6651670H

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
ToRC IgG Assay Protocol File CD, SW 4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002240 ()

  • 1 Each
6651670G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002158 ()

  • 1 Each
6651665D

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
ToRC IgG Reagent Pack
BIO-RAD LABORATORIES, INC.
6651650
In Commercial Distribution

  • 00847865000444 ()

  • 100 Number of Tests
6651650

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
ToRC IgG Control Lot Data
BIO-RAD LABORATORIES, INC.
6631640
In Commercial Distribution

  • 00847865000437 ()

  • 1 Each
6631640

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
  • Rubella virus immunoglobulin G (IgG) antibody IVD, control
ToRC IgG Control Set
BIO-RAD LABORATORIES, INC.
6631630
In Commercial Distribution

  • 00847865000420 ()

  • 6 Vials
  • Total Volume: 1.5 Milliliter
6631630

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
  • Rubella virus immunoglobulin G (IgG) antibody IVD, control
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
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