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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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Coxsackie B1-B6 Negative Control - B110CBN33100

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

  • B110CBN33100 ()
CBN-3310

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control

Coxsackie B1-B6 IgG Control - B110CBG33200

No Description
Bion Enterprises, Ltd.
CBG-3320
Not in Commercial Distribution

  • B110CBG33200 ()
CBG-3320

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control

Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System - B110CB33120

No Description
Bion Enterprises, Ltd.
CB-3312
In Commercial Distribution

  • B110CB33120 ()
CB-3312

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System - B110CB33060

No Description
Bion Enterprises, Ltd.
CB-3306
In Commercial Distribution

  • B110CB33060 ()
CB-3306

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

Celerity - 10724995218581

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

Influenza B IgG ELISA Test Kit - B350GSD0130100

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 - B350GSD0130090

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)

Elecsys Anti-HAV II - 07613336129722

No Description
Roche Diagnostics GmbH
08086630190
In Commercial Distribution

  • 07613336129722 ()
08086630190

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

Elecsys Anti-HAV II - 07613336129715

No Description
Roche Diagnostics GmbH
08086664190
In Commercial Distribution

  • 07613336129715 ()
08086664190

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

Chemdye® - 07798164672142

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

  • 07798164676843 ()
  • 07798164672142 ()


  • Chemical/physical sterilization process indicator
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