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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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MONOLISA™ - 00847865013123

Anti-HBc IgM EIA Conjugate Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26198
In Commercial Distribution

  • 00847865013123 ()

  • Total Volume: 30 Milliliter
26198

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

MONOLISA™ - 00847865013116

Anti-HBc EIA, Negative Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26197
In Commercial Distribution

  • 00847865013116 ()

  • Total Volume: 0.8 Milliliter
26197

  • Hepatitis B virus core antigen IVD, control

MONOLISA™ - 00847865013109

Anti-HBc EIA, Specimen Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26196
In Commercial Distribution

  • 00847865013109 ()

  • Total Volume: 30 Milliliter
26196

  • Hepatitis B virus core antigen IVD, reagent

MONOLISA™ - 00847865013093

Anti-HBc EIA, Cutoff Calibrator, 1.5 mL
Bio-RAD Laboratories, Inc.
26195
In Commercial Distribution

  • 00847865013093 ()

  • Total Volume: 1.5 Milliliter
26195

  • Hepatitis B virus core total antibody IVD, calibrator

MONOLISA™ - 00847865013086

Anti-HBc EIA, Positive Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26194
In Commercial Distribution

  • 00847865013086 ()

  • Total Volume: 0.8 Milliliter
26194

  • Hepatitis B virus core antigen IVD, control

MONOLISA™ - 00847865013079

Anti-HBc EIA, Conjugate Reagent 30 mL
Bio-RAD Laboratories, Inc.
26193
In Commercial Distribution

  • 00847865013079 ()

  • Total Volume: 30 Milliliter
26193

  • Hepatitis B virus core antigen IVD, reagent

MONOLISA™ - 00847865011372

MONOLISA™ Anti-HBc EIA 192 Tests
Bio-RAD Laboratories, Inc.
26186
In Commercial Distribution

  • 00847865011372 ()

  • 192 tests
26186

  • Hepatitis B virus core antigen IVD, kit, enzyme immunoassay (EIA)

MONOLISA™ - 00847865011365

MONOLISA™ Anti-HBc IgM EIA, 192 Tests
Bio-RAD Laboratories, Inc.
26174
In Commercial Distribution

  • 00847865011365 ()

  • 192 tests
26174

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

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

IMMULITE®/IMMULITE®1000 Systems aHB Anti-HBs - 00630414970998

aHB Anti-HBs Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10372452
Not in Commercial Distribution

  • 00630414970998 ()
LKAH1(D)

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

IMMULITE® 2000 Systems aBC Anti-HBc - 00630414970981

aBC Anti-HBc Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370306
In Commercial Distribution

  • 00630414970981 ()
L2KHC2(D)

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

IMMULITE®/IMMULITE®1000 Systems aBC Anti-HBc - 00630414970974

aBC Anti-HBc Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370305
Not in Commercial Distribution

  • 00630414970974 ()
LKHC1(D)

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

IMMULITE®1000 System ID4 ID4 Sample Diluent - 00630414960975

ID4 Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381266
In Commercial Distribution

  • 00630414960975 ()
  • 00630414601748 ()
L1KMCW1

  • Buffered sample diluent IVD

Atellica IM HBcT2 - 00630414637877

Atellica IM HBcT2 (REF) 500T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11643118
In Commercial Distribution

  • 00630414637877 ()
11643118

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

Atellica IM HBcT2 QC - 00630414604336

HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200740
In Commercial Distribution

  • 00630414604336 ()
11200740

  • Hepatitis B virus core total antibody IVD, control

Atellica IM HBcT2 - 00630414604138

HBc Total 2 (HBcT2) Atellica IM - RGT 100T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200739
In Commercial Distribution

  • 00630414604138 ()
11200739

  • Hepatitis B virus core total antibody 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

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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