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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 - 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

Alinity - 00380740136666

Alinity i Anti-HBc Reagent Kit 1200 Tests
Abbott GmbH
07P8431
In Commercial Distribution

  • 00380740136666 ()
07P8431

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

Alinity - 00380740136659

Alinity i Anti-HBc Reagent Kit 200 Tests
Abbott GmbH
07P8421
In Commercial Distribution

  • 00380740136659 ()
07P8421

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

Alinity - 00380740136642

Alinity i Anti-HBc Controls
Abbott GmbH
07P8410
In Commercial Distribution

  • 00380740136642 ()
07P8410

  • Hepatitis B virus core total antibody IVD, control

Alinity - 00380740136635

Alinity i Anti-HBc Calibrator
Abbott GmbH
07P8401
In Commercial Distribution

  • 00380740136635 ()
07P8401

  • Hepatitis B virus core total antibody IVD, calibrator

Alinity - 00380740136598

Alinity i HBsAg Qualitative II Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
08P1031
In Commercial Distribution

  • 00380740136598 ()
08P1031

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

Alinity - 00380740136581

Alinity i HBsAg Qualitative II Reagent Kit 200 Tests
Abbott Ireland Diagnostics
08P1021
In Commercial Distribution

  • 00380740136581 ()
08P1021

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

Alinity - 00380740130459

Alinity i HBsAg Qualitative II Confirmatory Reagent Kit 200 Tests
Abbott Ireland Diagnostics
08P1121
In Commercial Distribution

  • 00380740130459 ()
08P1121

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

Alinity - 00380740130282

Alinity i Anti-HBc IgM Reagent Kit 200 Tests
Abbott GmbH
07P8621
In Commercial Distribution

  • 00380740130282 ()
07P8621

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

ARCHITECT - 00380740115388

ARCHITECT AUSAB Specimen Diluent
Abbott Ireland Diagnostics
1L82-40
In Commercial Distribution

  • 00380740115388 ()
01L8240

  • Buffered sample diluent IVD

ARCHITECT - 00380740115371

ARCHITECT AUSAB Reagent
Abbott Ireland Diagnostics
1L82-37
In Commercial Distribution

  • 00380740115371 ()
01L8237

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