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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 - 00816426021013

For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
KAMIYA BIOMEDICAL COMPANY, LLC
K204C-10M
In Commercial Distribution

  • 00816426021013 ()
K204C-10M

  • Multiple coagulation factor IVD, control

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

Alinity - 00380740136628

Alinity i HAVAb IgM Reagent Kit 1000 Tests
Abbott GmbH
08P2831
In Commercial Distribution

  • 00380740136628 ()
08P2831

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

Alinity - 00380740136611

Alinity i HAVAb IgM Reagent Kit 200 Tests
Abbott GmbH
08P2821
In Commercial Distribution

  • 00380740136611 ()
08P2821

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

Alinity - 00380740131579

Alinity i HAVAb IgM Controls
Abbott GmbH
08P2810
In Commercial Distribution

  • 00380740131579 ()
08P2810

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control

Alinity - 00380740131562

Alinity i HAVAb IgM Calibrator
Abbott GmbH
08P2801
In Commercial Distribution

  • 00380740131562 ()
08P2801

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator
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