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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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PreciControl Anti-HBs - 07613336159798

No Description
Roche Diagnostics GmbH
11876317160
In Commercial Distribution

  • 07613336159798 ()
11876317160

  • Hepatitis B virus surface total antibody IVD, control

Elecsys Anti-HBs - 07613336159781

No Description
Roche Diagnostics GmbH
11820524160
In Commercial Distribution

11820524160

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

PreciControl HBsAg II - 07613336106402

No Description
Roche Diagnostics GmbH
04687876160
In Commercial Distribution

  • 07613336106402 ()
04687876160

  • Hepatitis B virus surface antigen IVD, control

Elecsys HBsAg II - 07613336106396

No Description
Roche Diagnostics GmbH
07914482160
Not in Commercial Distribution

  • 07613336106396 ()
07914482160

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

VITROS - 10758750001446

VITROS Immunodiagnostic Products HBeAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801819
In Commercial Distribution

  • 10758750001446 ()
  • 20758750001443 ()
6801819

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

VITROS - 10758750001439

VITROS Immunodiagnostic Products Anti-HBe Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801817
In Commercial Distribution

  • 10758750001439 ()
  • 20758750001436 ()
6801817

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

VITROS - 10758750001224

VITROS Immunodiagnostic Products Anti-HBc Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801429
In Commercial Distribution

  • 10758750001224 ()
  • 20758750001221 ()
6801429

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

VITROS - 10758750001217

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801428
In Commercial Distribution

  • 10758750001217 ()
  • 20758750001214 ()
6801428

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

VITROS - 10758750001194

VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801426
In Commercial Distribution

  • 10758750001194 ()
6801426

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

VITROS - 10758750001187

VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801425
In Commercial Distribution

  • 10758750001187 ()
6801425

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

VITROS - 10758750001088

VITROS Immunodiagnostic Products HBsAg Confirmatory Kit
ORTHO CLINICAL DIAGNOSTICS
6801324
In Commercial Distribution

  • 10758750001088 ()
  • 20758750001085 ()
6801324

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

VITROS - 10758750001071

VITROS Immunodiagnostic Products HBsAg Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801323
In Commercial Distribution

  • 10758750001071 ()
  • 20758750001078 ()
6801323

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

VITROS - 10758750001064

VITROS Immunodiagnostic Products HBsAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801322
In Commercial Distribution

  • 10758750001064 ()
  • 20758750001061 ()
6801322

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

VITROS - 10758750002795

VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801425
In Commercial Distribution

  • 10758750002795 ()
6801425

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

VITROS - 10758750002788

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802452
In Commercial Distribution

  • 10758750002788 ()
6802452

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

VITROS - 10758750002771

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802451
In Commercial Distribution

  • 10758750002771 ()
6802451

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

VITROS - 10758750002764

VITROS Immunodiagnostic Products HBsAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802450
In Commercial Distribution

  • 10758750002764 ()
6802450

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

VITROS - 10758750001699

VITROS Immunodiagnostic Products Anti-HBs Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801926
In Commercial Distribution

  • 10758750001699 ()
  • 20758750001696 ()
6801926

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

VITROS - 10758750001682

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801925
In Commercial Distribution

  • 10758750001682 ()
  • 20758750001689 ()
6801925

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

VITROS - 10758750001453

VITROS Immunodiagnostic Products HBeAg Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801820
In Commercial Distribution

  • 10758750001453 ()
  • 20758750001450 ()
6801820

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

VITROS - 10758750001422

VITROS Immunodiagnostic Products Anti-HBe Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801816
In Commercial Distribution

  • 10758750001422 ()
  • 20758750001429 ()
6801816

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

ARCHITECT - 00380740001513

ARCHITECT AUSAB Reagent Kit
Abbott Ireland Diagnostics
1L82-25
In Commercial Distribution

  • 00380740001513 ()
01L8225

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

ARCHITECT - 00380740001506

ARCHITECT AUSAB Controls
Abbott Ireland Diagnostics
1L82-12
In Commercial Distribution

  • 00380740001506 ()
01L8212

  • Hepatitis B virus surface total antibody IVD, control

ARCHITECT - 00380740001490

ARCHITECT AUSAB Calibrators
Abbott Ireland Diagnostics
1L82-02
In Commercial Distribution

  • 00380740001490 ()
01L8202

  • Hepatitis B virus surface total antibody IVD, calibrator

ARCHITECT - 00380740001520

ARCHITECT AUSAB Reagent Kit
Abbott Ireland Diagnostics
1L82-35
In Commercial Distribution

  • 00380740001520 ()
01L8235

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

ARCHITECT - 00380740011154

ARCHITECT CORE-M Reagent Kit
Abbott GmbH
6L23-25
In Commercial Distribution

  • 00380740011154 ()
06L2325

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

ARCHITECT - 00380740011147

ARCHITECT CORE-M Controls
Abbott GmbH
6L23-10
In Commercial Distribution

  • 00380740011147 ()
06L2310

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

ARCHITECT - 00380740011130

ARCHITECT CORE-M Calibrators
Abbott GmbH
6L23-01
In Commercial Distribution

  • 00380740011130 ()
06L2301

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

ARCHITECT - 00380740011123

ARCHITECT CORE Reagent Kit
Abbott GmbH
6L22-25
In Commercial Distribution

  • 00380740011123 ()
06L2225

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

ARCHITECT - 00380740011116

ARCHITECT CORE Controls
Abbott GmbH
6L22-10
In Commercial Distribution

  • 00380740011116 ()
06L2210

  • Hepatitis B virus core total antibody IVD, control

ARCHITECT - 00380740011109

ARCHITECT CORE Calibrator
Abbott GmbH
6L22-01
In Commercial Distribution

  • 00380740011109 ()
06L2201

  • Hepatitis B virus core total antibody IVD, calibrator

ARCHITECT - 00380740007799

ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit
Abbott Ireland Diagnostics
4P54-25
In Commercial Distribution

  • 00380740007799 ()
04P5425

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

ARCHITECT - 00380740007775

ARCHITECT HBsAg Qualitative Reagent Kit
Abbott Ireland Diagnostics
4P53-25
In Commercial Distribution

  • 00380740007775 ()
04P5325

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

ARCHITECT - 00380740007751

ARCHITECT HBsAg Qualitative Calibrators
Abbott Ireland Diagnostics
4P53-01
In Commercial Distribution

  • 00380740007751 ()
04P5301

  • Hepatitis B virus surface antigen IVD, calibrator

Alinity - 00380740161262

Alinity i HBsAg Next Confirmatory Reagent Kit (200T)
Abbott Ireland Diagnostics
01R6521
In Commercial Distribution

  • 00380740161262 ()
01R6521

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

Alinity - 00380740160593

Alinity i HBsAg Next Qualitative Reagent Kit (1200T)
Abbott Ireland Diagnostics
01R6431
In Commercial Distribution

  • 00380740160593 ()
01R6431

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

Alinity - 00380740160579

Alinity i HBsAg Next Qualitative Reagent Kit (200T)
Abbott Ireland Diagnostics
01R6421
In Commercial Distribution

  • 00380740160579 ()
01R6421

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

ARCHITECT - 00380740158187

ARCHITECT HBsAg Next Confirmatory Reagent Kit (100T)
Abbott Ireland Diagnostics
4P77-27
In Commercial Distribution

  • 00380740158187 ()
04P7727

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

ARCHITECT - 00380740157012

ARCHITECT HBsAg Next Qualitative Reagent Kit (500T)
Abbott Ireland Diagnostics
4P76-37
In Commercial Distribution

  • 00380740157012 ()
04P7637

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

ARCHITECT - 00380740156992

ARCHITECT HBsAg Next Qualitative Reagent Kit (100T)
Abbott Ireland Diagnostics
4P76-27
In Commercial Distribution

  • 00380740156992 ()
04P7627

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

Alinity - 00380740151300

Alinity i Anti-HBs Controls
Abbott Ireland Diagnostics
07P8810
In Commercial Distribution

  • 00380740151300 ()
07P8810

  • Hepatitis B virus surface total antibody IVD, control

Alinity - 00380740149611

Alinity i Anti-HBs Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P8856
In Commercial Distribution

  • 00380740149611 ()
07P8856

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

Alinity - 00380740149604

Alinity i Anti-HBs Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P8851
In Commercial Distribution

  • 00380740149604 ()
07P8851

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

Alinity - 00380740149598

Alinity i Anti-HBs Specimen Diluent
Abbott Ireland Diagnostics
07P8841
In Commercial Distribution

  • 00380740149598 ()
07P8841

  • Buffered sample diluent IVD

Alinity - 00380740149574

Alinity i Anti-HBs Calibrators
Abbott Ireland Diagnostics
07P8801
In Commercial Distribution

  • 00380740149574 ()
07P8801

  • Hepatitis B virus surface total antibody IVD, calibrator

Alinity - 00380740146245

Alinity i HBsAg Qualitative II Controls
Abbott Ireland Diagnostics
08P1012
In Commercial Distribution

  • 00380740146245 ()
08P1012

  • Hepatitis B virus surface antigen IVD, control

Alinity - 00380740146238

Alinity i HBsAg Qualitative II Calibrators
Abbott Ireland Diagnostics
08P1002
In Commercial Distribution

  • 00380740146238 ()
08P1002

  • Hepatitis B virus surface antigen IVD, calibrator

Alinity - 00380740146214

Alinity i HBsAg Qualitative II Confirmatory Manual Diluent 1 Tests
Abbott Ireland Diagnostics
08P1141
In Commercial Distribution

  • 00380740146214 ()
08P1141

  • Buffered sample diluent IVD

Alinity - 00380740146177

Alinity i Anti-HBc IgM Calibrators
Abbott GmbH
07P8602
In Commercial Distribution

  • 00380740146177 ()
07P8602

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

Alinity - 00380740145187

Alinity i Anti-HBc IgM Controls
Abbott GmbH
07P8612
In Commercial Distribution

  • 00380740145187 ()
07P8612

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