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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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K-ASSAY® Coagulation Control - 00816426020924

For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
KAMIYA BIOMEDICAL COMPANY, LLC
K104C-10M
Not in Commercial Distribution

  • 00816426020924 ()
K104C-10M

  • Multiple coagulation factor IVD, control

K-ASSAY® Factor XIII Calibrator - 00816426020764

For the calibration of the K-ASSAY® Factor XIII assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-206C
In Commercial Distribution

  • 00816426020764 ()
KAI-206C

  • Coagulation factor XIII IVD, calibrator

K-ASSAY® Factor XIII Calibrator - 00816426020719

For the calibration of the K-ASSAY® Factor XIII assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-106C
In Commercial Distribution

  • 00816426020719 ()
KAI-106C

  • Coagulation factor XIII IVD, calibrator

K-ASSAY® Factor XIII Reagent - 00816426020535

For the quantitative determination of human coagulation factor XIII in plasma.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-205
In Commercial Distribution

  • 00816426020535 ()
KAI-205

  • Coagulation factor XIII IVD, reagent

K-ASSAY® Factor XIII Reagent - 00816426020467

For the quantitative determination of human coagulation factor XIII in plasma by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-105
In Commercial Distribution

  • 00816426020467 ()
KAI-105

  • Coagulation factor XIII IVD, reagent

VITROS - 10758750008926

VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator
ORTHO CLINICAL DIAGNOSTICS
1372101
In Commercial Distribution

  • 10758750008926 ()
  • 20758750008923 ()
1372101

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001477

VITROS Immunodiagnostic Products HAV Total Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801823
In Commercial Distribution

  • 10758750001477 ()
  • 20758750001474 ()
6801823

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001415

VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801812
In Commercial Distribution

  • 10758750001415 ()
  • 20758750001412 ()
6801812

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001286

VITROS Immunodiagnostic Products Anti-HAV Total Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801462
In Commercial Distribution

  • 10758750001286 ()
  • 20758750001283 ()
6801462

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay

3M™ Attest™ - 30707387788019

3M™ Attest™ VH2O2 Tri-Metric Chemical Indicator, 250 each/pouch, 4 pouches/case, 1348E
3M COMPANY
1348E
In Commercial Distribution

  • 50707387788013 ()
  • 30707387788019 ()
  • 00707387788018 ()
1348E

  • Chemical/physical sterilization process indicator
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