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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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ADVIA Centaur® HBeAg - 00630414591315

Hepatitis B e Antigen (HBeAg) Assay Kit (1-pack) 50T
Siemens Healthcare Diagnostics Inc.
10698639
In Commercial Distribution

  • 00630414591315 ()
10698639

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® HBcT - 00630414498096

HBc Total (HBcT) Assay Kit 200T
Siemens Healthcare Diagnostics Inc.
10309508
In Commercial Distribution

  • 00630414498096 ()
7566733

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems HBcT QC - 00630414498089

HBc Total (HBcT) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309509
In Commercial Distribution

  • 00630414498089 ()
7569996

  • Hepatitis B virus core total antibody IVD, control

ADVIA Centaur® Systems HBsAg QC - 00630414472881

HBsAg (HBs) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309059
In Commercial Distribution

  • 00630414472881 ()
3394660

  • Hepatitis B virus surface antigen IVD, control

ADVIA Centaur® HBsAg - 00630414472867

HBsAg (HBs) (1-pack) 200T Assay Kit
Siemens Healthcare Diagnostics Inc.
10309057
In Commercial Distribution

  • 00630414472867 ()
3393362

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® aHBs - 00630414471914

Anti-HBs (aHBs) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10309021
Not in Commercial Distribution

  • 00630414471914 ()
1463789

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems aHBs QC - 00630414471860

Anti-HBs (aHBs) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309020
Not in Commercial Distribution

  • 00630414471860 ()
1453546

  • Hepatitis B virus surface total antibody IVD, control

ADVIA Centaur® Systems HBc IgM QC - 00630414470504

HBc IgM (aHBcM) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10308979
In Commercial Distribution

  • 00630414470504 ()
504945

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

Atellica IM HBsII - 00630414301327

HBsAgII (HBsII) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207286
In Commercial Distribution

  • 00630414301327 ()
11207286

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Atellica IM HBeAg - 00630414301310

Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
11207281
In Commercial Distribution

  • 00630414301310 ()
11207281

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
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