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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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VITROS Immunodiagnostic Products Anti-HBe Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801816
In Commercial Distribution

  • 10758750001422 ()
  • 20758750001429 ()
6801816

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT AUSAB Reagent Kit
Abbott Ireland Diagnostics
1L82-25
In Commercial Distribution

  • 00380740001513 ()
01L8225

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT AUSAB Controls
Abbott Ireland Diagnostics
1L82-12
In Commercial Distribution

  • 00380740001506 ()
01L8212

  • Hepatitis B virus surface total antibody IVD, control
ARCHITECT AUSAB Calibrators
Abbott Ireland Diagnostics
1L82-02
In Commercial Distribution

  • 00380740001490 ()
01L8202

  • Hepatitis B virus surface total antibody IVD, calibrator
ARCHITECT AUSAB Reagent Kit
Abbott Ireland Diagnostics
1L82-35
In Commercial Distribution

  • 00380740001520 ()
01L8235

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT CORE-M Reagent Kit
Abbott GmbH
6L23-25
In Commercial Distribution

  • 00380740011154 ()
06L2325

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT CORE-M Controls
Abbott GmbH
6L23-10
In Commercial Distribution

  • 00380740011147 ()
06L2310

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
ARCHITECT CORE-M Calibrators
Abbott GmbH
6L23-01
In Commercial Distribution

  • 00380740011130 ()
06L2301

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator
ARCHITECT CORE Reagent Kit
Abbott GmbH
6L22-25
In Commercial Distribution

  • 00380740011123 ()
06L2225

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT CORE Controls
Abbott GmbH
6L22-10
In Commercial Distribution

  • 00380740011116 ()
06L2210

  • Hepatitis B virus core total antibody IVD, control
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