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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® HBsAg Conf (Confirmatory) - 00630414472874

HBsAg Conf (Confirmatory) Assay Kit
Siemens Healthcare Diagnostics Inc.
10309058
In Commercial Distribution

  • 00630414472874 ()
3393818

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

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

ADVIA Centaur® HBc IgM - 00630414470498

HBc IgM (aHBcM) Assay Kit - 100T
Siemens Healthcare Diagnostics Inc.
10308978
In Commercial Distribution

  • 00630414470498 ()
504619

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

Atellica IM Calibrator D - 00630414293561

Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206244
In Commercial Distribution

  • 00630414294117 ()
  • 00630414293561 ()
11206244

  • Multiple tissue-associated protein/tumour marker IVD, calibrator

Atellica IM AFP - 00630414238791

Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202257
In Commercial Distribution

  • 00630414238791 ()
11202257

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q - 00630414202938

Calibrator Q - 2 pack (PSA Cal)
Siemens Healthcare Diagnostics Inc.
10310295
In Commercial Distribution

  • 00630414202938 ()
118220

  • Total prostate specific antigen (tPSA) IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems Calibrator Q - 00630414202921

Calibrator Q - 6 pack (PSA Cal)
Siemens Healthcare Diagnostics Inc.
10310296
In Commercial Distribution

  • 00630414202921 ()
118221

  • Total prostate specific antigen (tPSA) IVD, calibrator
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