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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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ARCHITECT - 00380740115364

ARCHITECT AUSAB Reagent
Abbott Ireland Diagnostics
1L82-27
In Commercial Distribution

  • 00380740115364 ()
01L8227

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

ARCHITECT - 00380740105433

ARCHITECT AUSAB Reagent
Abbott Ireland Diagnostics
1L82-36
In Commercial Distribution

  • 00380740105433 ()
01L8236

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

ARCHITECT - 00380740105426

ARCHITECT AUSAB Reagent
Abbott Ireland Diagnostics
1L82-26
In Commercial Distribution

  • 00380740105426 ()
01L8226

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

ARCHITECT - 00380740105419

ARCHITECT AUSAB Controls
Abbott Ireland Diagnostics
1L82-13
In Commercial Distribution

  • 00380740105419 ()
01L8213

  • Hepatitis B virus surface total antibody IVD, control

ARCHITECT - 00380740105402

ARCHITECT AUSAB Calibrators
Abbott Ireland Diagnostics
1L82-03
In Commercial Distribution

  • 00380740105402 ()
01L8203

  • Hepatitis B virus surface total antibody IVD, calibrator

ARCHITECT - 00380740007805

ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent
Abbott Ireland Diagnostics
4P54-40
In Commercial Distribution

  • 00380740007805 ()
04P5440

  • Buffered sample diluent IVD

ARCHITECT - 00380740007782

ARCHITECT HBsAg Qualitative Reagent Kit
Abbott Ireland Diagnostics
4P53-35
In Commercial Distribution

  • 00380740007782 ()
04P5335

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

ARCHITECT - 00380740007768

ARCHITECT HBsAg Qualitative Controls
Abbott Ireland Diagnostics
4P53-10
In Commercial Distribution

  • 00380740007768 ()
04P5310

  • Hepatitis B virus surface antigen IVD, control

Alinity - 00380740214302

Alinity i HBsAg Next Qualitative Controls
Abbott Ireland Diagnostics
01R6412
In Commercial Distribution

  • 00380740214302 ()
01R6412

  • Hepatitis B virus surface antigen IVD, control

Alinity - 00380740214296

Alinity i HBsAg Next Qualitative Calibrators
Abbott Ireland Diagnostics
01R6402
In Commercial Distribution

  • 00380740214296 ()
01R6402

  • Hepatitis B virus surface antigen IVD, calibrator

Alinity - 00380740214289

Alinity i HBsAg Next Confirmatory Manual Diluent
Abbott Ireland Diagnostics
01R6542
In Commercial Distribution

  • 00380740214289 ()
01R6542

  • Buffered sample diluent IVD

ARCHITECT - 00380740208486

ARCHITECT HBsAg Next Qualitative Calibrators
Abbott Ireland Diagnostics
4P76-02
In Commercial Distribution

  • 00380740208486 ()
04P7602

  • Hepatitis B virus surface antigen IVD, calibrator

ARCHITECT - 00380740208479

ARCHITECT HBsAg Next Confirmatory Manual Diluent
Abbott Ireland Diagnostics
4P77-42
In Commercial Distribution

  • 00380740208479 ()
04P7742

  • Buffered sample diluent IVD

ARCHITECT - 00380740208462

ARCHITECT HBsAg Next Qualitative Controls
Abbott Ireland Diagnostics
4P76-12
In Commercial Distribution

  • 00380740208462 ()
04P7612

  • Hepatitis B virus surface antigen IVD, control

Alinity - 00380740173562

Alinity i Anti-HBs Reagent Kit (1200T)
Abbott Ireland Diagnostics
07P8857
In Commercial Distribution

  • 00380740173562 ()
07P8857

  • Hepatitis B virus surface total antibody IVD, reagent

Alinity - 00380740173555

Alinity i Anti-HBs Reagent Kit (200T)
Abbott Ireland Diagnostics
07P8852
In Commercial Distribution

  • 00380740173555 ()
07P8852

  • Hepatitis B virus surface total antibody IVD, reagent

ARCHITECT - 00380740171759

ARCHITECT AUSAB Reagent Kit (500T)
Abbott Ireland Diagnostics
01L8238
In Commercial Distribution

  • 00380740171759 ()
01L8238

  • Hepatitis B virus surface total antibody IVD, reagent

ARCHITECT - 00380740171742

ARCHITECT AUSAB Reagent Kit (100T)
Abbott Ireland Diagnostics
01L8228
In Commercial Distribution

  • 00380740171742 ()
01L8228

  • Hepatitis B virus surface total antibody IVD, reagent

ARCHITECT - 00380740163389

ARCHITECT HBsAg Next Qualitative Reagent Kit (2000T)
Abbott Ireland Diagnostics
4P76-32
In Commercial Distribution

  • 00380740163389 ()
04P7632

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

Atellica IM aHBe2 - 00842768022678

Anti-HBe2 (aHBe2) – Atellica IM – RGT 50T
Siemens Healthcare Diagnostics Inc.
10733021
In Commercial Distribution

  • 00842768022678 ()
10733021

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

Elecsys PreciControl Anti-HBc IgM - 04015630911622

No Description
Roche Diagnostics GmbH
11876333160
Not in Commercial Distribution

  • 04015630911622 ()
11876333160

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

Elecsys Anti-HBc IgM Immunoassay - 04015630911615

No Description
Roche Diagnostics GmbH
11820567160
Not in Commercial Distribution

  • 04015630911615 ()
11820567160

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

Elecsys HBsAg Immunoassay - 04015630911073

No Description
Roche Diagnostics GmbH
11820532160
In Commercial Distribution

  • 04015630911073 ()
11820532160

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

Elecsys PreciControl HBsAg - 04015630911059

No Description
Roche Diagnostics GmbH
11876309160
Not in Commercial Distribution

  • 04015630911059 ()
11876309160

  • Hepatitis B virus surface antigen IVD, control

Elecsys Anti-HBs Immunoassay - 04015630919420

No Description
Roche Diagnostics GmbH
11820524160
Not in Commercial Distribution

  • 04015630919420 ()
11820524160

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

Elecsys HBeAg - 04015630939862

No Description
Roche Diagnostics GmbH
07027427190
In Commercial Distribution

  • 04015630939862 ()
07027427190

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

Elecsys HBsAg II - 04015630939008

No Description
Roche Diagnostics GmbH
04687787160
Not in Commercial Distribution

  • 04015630939008 ()
04687787160

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

PreciControl Anti-HBe - 04015630938872

Anti-HBe PC Elecsys
Roche Diagnostics GmbH
11876384160
In Commercial Distribution

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control

Elecsys Anti-HBe - 04015630938865

No Description
Roche Diagnostics GmbH
11820613160
In Commercial Distribution

  • 04015630938865 ()
11820613160

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

Elecsys HBeAg immunoassay - 04015630935215

No Description
Roche Diagnostics GmbH
11820583160
Not in Commercial Distribution

  • 04015630935215 ()
11820583160

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