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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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HBsAg (HBs) (1-pack) 200T Assay Kit
Siemens Healthcare Diagnostics Inc.
10309057
In Commercial Distribution

  • 00630414472867 ()
3393362

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Anti-HBs (aHBs) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10309021
Not in Commercial Distribution

  • 00630414471914 ()
1463789

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs (aHBs) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309020
Not in Commercial Distribution

  • 00630414471860 ()
1453546

  • Hepatitis B virus surface total antibody IVD, control
HBc IgM (aHBcM) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10308979
In Commercial Distribution

  • 00630414470504 ()
504945

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
HBc IgM (aHBcM) Assay Kit - 100T
Siemens Healthcare Diagnostics Inc.
10308978
In Commercial Distribution

  • 00630414470498 ()
504619

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HBsAgII (HBsII) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207286
In Commercial Distribution

  • 00630414301327 ()
11207286

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
11207281
In Commercial Distribution

  • 00630414301310 ()
11207281

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
HBC Total Ab (HBcT) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207276
In Commercial Distribution

  • 00630414301303 ()
11207276

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207255
In Commercial Distribution

  • 00630414301273 ()
11207255

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207249
In Commercial Distribution

  • 00630414301266 ()
11207249

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Anti-HBe2 (aHBe2) – ADVIA Centaur – RGT 50T
Siemens Healthcare Diagnostics Inc.
10720831
In Commercial Distribution

  • 00630414167923 ()
10720831

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL
Bio-RAD Laboratories, Inc.
26203
In Commercial Distribution

  • 00847865013178 ()

  • Total Volume: 1.5 Milliliter
26203

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, control
Anti-HBc IgM EIA, Conjugate, Lyophilized, 7.5 mL
Bio-RAD Laboratories, Inc.
26202
In Commercial Distribution

  • 00847865013161 ()

  • Total Volume: 7.5 Milliliter
26202

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent
Anti-HBc IgM EIA, Negative Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26201
In Commercial Distribution

  • 00847865013154 ()

  • Total Volume: 0.8 Milliliter
26201

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Anti-HBc IgM EIA, Positive Control,1.6 mL
Bio-RAD Laboratories, Inc.
26200
In Commercial Distribution

  • 00847865013147 ()

  • Total Volume: 1.6 Milliliter
26200

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Anti-HBc IgM EIA, Specimen Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26199
In Commercial Distribution

  • 00847865013130 ()

  • Total Volume: 30 Milliliter
26199

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