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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® HBsII - 00630414578170

HBsAgII (HBsII) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10492138
In Commercial Distribution

  • 00630414578170 ()
10492138

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

ADVIA Centaur® aHBs2 - 00630414561790

Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10286268
In Commercial Distribution

  • 00630414561790 ()
4670661

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

ADVIA Centaur® HBcT2 Quality Control Kit - 00630414561233

ADVIA Centaur® HBcT2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10376699
In Commercial Distribution

  • 00630414210766 ()
  • 00630414561233 ()
10376699

  • Hepatitis B virus core total antibody IVD, control

ADVIA Centaur® HBcT2 - 00630414561226

ADVIA Centaur® HBcT2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10376698
In Commercial Distribution

  • 00630414561226 ()
10376698

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

IMMULITE® 2000 Systems HBsAg Confirmatory Kit - 00630414947433

HBsAg Confirmatory Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706825
In Commercial Distribution

  • 00630414947433 ()
L2KCH1(D)

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

Atellica IM cPSA QC - 00630414598710

Complexed Prostate Specific Antigen (cPSA) QC Kit - Atellica IM - CLT 3 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995547
In Commercial Distribution

  • 00630414598710 ()
10995547

  • Complexed prostate specific antigen (cPSA) IVD, control

Atellica IM cPSA PRE - 00630414598703

Complexed Prostate Specific Antigen (cPSA) Pretreatment - Atellica IM - CONS (1PK) 1 x 5mL
Siemens Healthcare Diagnostics Inc.
10995546
In Commercial Distribution

  • 00630414598703 ()
10995546

  • Complexed prostate specific antigen (cPSA) IVD, reagent

Atellica IM cPSA - 00630414598680

Complexed Prostate Specific Antigen (cPSA) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995544
In Commercial Distribution

  • 00630414598680 ()
10995544

  • Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay

Atellica™ IM aHBs2 - 00630414597836

Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995453
In Commercial Distribution

  • 00630414597836 ()
10995453

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

IMMULITE®Systems sPS CONTROL Third Generation PSA - 00630414982281

sPS Third Generation PSA Control Module
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10708295
In Commercial Distribution

  • 00630414982281 ()
  • 00630414601793 ()
LUPCM(D)

  • Total prostate specific antigen (tPSA) IVD, control
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