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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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Liquichek ToRCH Plus Control, Negative MiniPak (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
228X
In Commercial Distribution

  • 00847661000532 ()
228X

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Multiple infectious organism/newborn TORCH screen IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
  • Treponema pallidum reagin antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
Liquichek ToRCH Plus Control, Positive MiniPak (An unassayed (human) Serology control.)
BIO-RAD LABORATORIES, INC.
239X
In Commercial Distribution

  • 00847661000495 ()
239X

  • Multiple infectious organism/newborn TORCH screen IVD, control
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
  • Treponema pallidum reagin antibody IVD, control
Liquichek ToRCH Plus Control, Negative (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
228
In Commercial Distribution

  • 00847661000259 ()
228

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
  • Treponema pallidum reagin antibody IVD, control
  • Multiple infectious organism/newborn TORCH screen IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
Liquichek ToRCH Plus Control, Positive (An unassayed (human) Serology control.)
BIO-RAD LABORATORIES, INC.
239
In Commercial Distribution

  • 00847661000235 ()
239

  • Treponema pallidum reagin antibody IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Multiple infectious organism/newborn TORCH screen IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
Immunoglobulin M Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444984
In Commercial Distribution

  • 00842768005732 ()
  • 00630414004600 ()
DF81

  • Immunoglobulin M subclass (IgM subclass) IVD, kit, nephelometry/turbidimetry
Immunoglobulin A Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444982
In Commercial Distribution

  • 00842768005688 ()
  • 00630414004587 ()
DF74

  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry
No Description
SEBIA
4642
In Commercial Distribution

  • 03607360046425 ()
4642

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
4639
In Commercial Distribution

  • 03607360046395 ()
4639

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
2601
In Commercial Distribution

  • 03607360026014 ()
2601

  • Multiple clinical chemistry protein IVD, reagent
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