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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® aHBs2 - 00630414591407

Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10698706
In Commercial Distribution

  • 00630414591407 ()
10698706

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

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® 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

ADVIA Centaur® Systems aHBs2 QC - 00630414551777

Anti-HBs2 (aHBs2) Quality Control Material
Siemens Healthcare Diagnostics Inc.
10283088
In Commercial Distribution

  • 00630414551777 ()
6521435

  • Hepatitis B virus surface total antibody IVD, control

ADVIA Centaur® Systems HBeAg QC - 00630414531298

Hepatitis B e Antigen (HBeAg) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10338289
In Commercial Distribution

  • 00630414531298 ()
6981117

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control

IMMULITE®/IMMULITE®1000 Systems HBS HBsAg - 00630414971551

HBS HBsAg Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374038
Not in Commercial Distribution

  • 00630414971551 ()
LKHB1(D)

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

IMMULITE® 2000 Systems HBS HBsAg - 00630414971438

HBS HBsAg Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374014
In Commercial Distribution

  • 00630414971438 ()
L2KHB2(D)

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