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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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Elecsys PreciControl Anti-HBc IgM - 04015630911622

No Description
Roche Diagnostics GmbH
11876333160
Not in Commercial Distribution

  • 04015630911622 ()
11876333160

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

Elecsys Anti-HBc IgM Immunoassay - 04015630911615

No Description
Roche Diagnostics GmbH
11820567160
Not in Commercial Distribution

  • 04015630911615 ()
11820567160

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

Elecsys HBsAg Immunoassay - 04015630911073

No Description
Roche Diagnostics GmbH
11820532160
In Commercial Distribution

  • 04015630911073 ()
11820532160

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

Elecsys PreciControl HBsAg - 04015630911059

No Description
Roche Diagnostics GmbH
11876309160
Not in Commercial Distribution

  • 04015630911059 ()
11876309160

  • Hepatitis B virus surface antigen IVD, control

Elecsys Anti-HBs Immunoassay - 04015630919420

No Description
Roche Diagnostics GmbH
11820524160
Not in Commercial Distribution

  • 04015630919420 ()
11820524160

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

Elecsys HBeAg - 04015630939862

No Description
Roche Diagnostics GmbH
07027427190
In Commercial Distribution

  • 04015630939862 ()
07027427190

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

Elecsys HBsAg II - 04015630939008

No Description
Roche Diagnostics GmbH
04687787160
Not in Commercial Distribution

  • 04015630939008 ()
04687787160

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

PreciControl Anti-HBe - 04015630938872

Anti-HBe PC Elecsys
Roche Diagnostics GmbH
11876384160
In Commercial Distribution

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control

Elecsys Anti-HBe - 04015630938865

No Description
Roche Diagnostics GmbH
11820613160
In Commercial Distribution

  • 04015630938865 ()
11820613160

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

Elecsys HBeAg immunoassay - 04015630935215

No Description
Roche Diagnostics GmbH
11820583160
Not in Commercial Distribution

  • 04015630935215 ()
11820583160

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

Elecsys PreciControl HBeAg - 04015630934843

No Description
Roche Diagnostics GmbH
11876376160
Not in Commercial Distribution

  • 04015630934843 ()
11876376160

  • Hepatitis B virus e-antigen IVD, control

Elecsys PreciControl Anti-HBs - 04015630910908

No Description
Roche Diagnostics GmbH
11876317160
Not in Commercial Distribution

  • 04015630910908 ()
11876317160

  • Hepatitis B virus surface total antibody IVD, control

Elecsys Anti-HBs CalCheck - 04015630999286

No Description
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution

  • 04015630999286 ()
04985354160

  • Hepatitis B virus surface total antibody IVD, control

Elecsys HBsAg II - 04015630940028

No Description
Roche Diagnostics GmbH
07251076190
Not in Commercial Distribution

  • 04015630940028 ()
07251076190

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

Elecsys PreciControl Anti-HBc - 04015630923045

No Description
Roche Diagnostics GmbH
04927931160
Not in Commercial Distribution

  • 04015630923045 ()
04927931160

  • Hepatitis B virus core total antibody IVD, control

Elecsys Anti-HBc Immunoassay - 04015630923038

No Description
Roche Diagnostics GmbH
04927826160
Not in Commercial Distribution

  • 04015630923038 ()
04927826160

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

MONOLISA™ - 00847865002103

Anti-HBs EIA, Conjugate Diluent 15 mL
Bio-RAD Laboratories, Inc.
26155
In Commercial Distribution

  • 00847865002103 ()

  • Total Volume: 15 Milliliter
26155

  • Hepatitis B virus surface total antibody IVD, reagent

GS - 00847865001861

HBsAg EIA 3.0 Conjugate Diluent, 120 mL
Bio-RAD Laboratories, Inc.
25104
In Commercial Distribution

  • 00847865001861 ()

  • Total Volume: 120 Milliliter
25104

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

Trinity Biotech - 05391516746311

Marblot Bordetella IgG PLUS, Western Blot System for the Detection of IgG Antibodies to Bordetella pertussis, 40 Tests
MARDX DIAGNOSTICS, INC.
40-6020P
In Commercial Distribution

  • 05391516746311 ()
40-6020P

  • Bordetella pertussis total antibody IVD, kit, immunoblot

Trinity Biotech - 05391516747899

B. Pertussis PT/FHA EIA Test System, EIA for the detection of antibody to Bordetella pertussis PT and FHA, 96 Tests
MARDX DIAGNOSTICS, INC.
40-6196P
In Commercial Distribution

  • 05391516747899 ()
40-6196P

  • Bordetella pertussis total antibody IVD, kit, immunoblot
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