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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™ - 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
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