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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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No Description
Bion Enterprises, Ltd.
CBN-3310
Not in Commercial Distribution

  • B110CBN33100 ()
CBN-3310

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CBG-3320
Not in Commercial Distribution

  • B110CBG33200 ()
CBG-3320

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CB-3312
In Commercial Distribution

  • B110CB33120 ()
CB-3312

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
CB-3306
In Commercial Distribution

  • B110CB33060 ()
CB-3306

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent
Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Flexible, Fast Non Lumen, Fast sterilization cycle of a V-PRO Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD System, including those systems with ALLClear Technology.
ALBERT BROWNE LIMITED
PCC079
In Commercial Distribution

  • 50724995218589 ()
  • 10724995218581 ()
  • 00724995218584 ()
PCC079

  • Chemical/physical sterilization process indicator
Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Influenza A IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3009
In Commercial Distribution

  • B350GSD0130090 ()
GSD01-3009

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08086630190
In Commercial Distribution

  • 07613336129722 ()
08086630190

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08086664190
In Commercial Distribution

  • 07613336129715 ()
08086664190

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.
TERRAGENE S.A.
CD40
In Commercial Distribution

  • 07798164676843 ()
  • 07798164672142 ()


  • Chemical/physical sterilization process indicator
Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.
TERRAGENE S.A.
CD40
In Commercial Distribution

  • 07798164676843 ()
  • 07798164672135 ()


  • Chemical/physical sterilization process indicator
For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.
KAMIYA BIOMEDICAL COMPANY, LLC
K204C-10M
Not in Commercial Distribution

  • 00816426021129 ()
K204C-10M

  • Multiple coagulation factor IVD, control
For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.
KAMIYA BIOMEDICAL COMPANY, LLC
K135C-10M
In Commercial Distribution

  • 00816426021099 ()
K135C-10M

  • Multiple coagulation factor IVD, control
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
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
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
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
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
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 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
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