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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
Roche Diagnostics GmbH
11876376160
In Commercial Distribution

11876376160

  • Hepatitis B virus e-antigen IVD, control
No Description
Roche Diagnostics GmbH
11820583160
In Commercial Distribution

11820583160

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08343594160
In Commercial Distribution

  • 07613336154014 ()
08343594160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
04927931161
In Commercial Distribution

  • 07613336153949 ()
04927931161

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
07026811160
In Commercial Distribution

  • 07613336153932 ()
07026811160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07026790160
Not in Commercial Distribution

  • 07613336153925 ()
07026790160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs EIA, Conjugate Diluent 15 mL
Bio-RAD Laboratories, Inc.
26155
In Commercial Distribution

  • 00847865002103 ()

  • Total Volume: 15 Milliliter
26155

  • Hepatitis B virus surface total antibody IVD, reagent
HBsAg EIA 3.0 Conjugate Diluent, 120 mL
Bio-RAD Laboratories, Inc.
25104
In Commercial Distribution

  • 00847865001861 ()

  • Total Volume: 120 Milliliter
25104

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
B. Pertussis PT/FHA EIA Test System, EIA for the detection of antibody to Bordetella pertussis PT and FHA, 96 Tests
MARDX DIAGNOSTICS, INC.
40-6196P
In Commercial Distribution

  • 05391516747899 ()
40-6196P

  • Bordetella pertussis total antibody IVD, kit, immunoblot
B. pertussis WB Negative Control, 250 µL
MARDX DIAGNOSTICS, INC.
40-6111
In Commercial Distribution

  • 05391516747882 ()
40-6111

  • Bordetella pertussis total antibody IVD, control
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