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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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IMMULITE® 2000 Systems BcM Anti-HBc IgM - 00630414977737

BcM Anti-HBc IgM Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488616
In Commercial Distribution

  • 00630414977737 ()
L2KMC2(D)

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

IMMULITE®/IMMULITE®1000 Systems BcM Anti-HBc IgM - 00630414977720

BcM Anti-HBc IgM Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488615
Not in Commercial Distribution

  • 00630414977720 ()
LKMC1(D)

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

Atellica IM aHBe2 - 00842768022678

Anti-HBe2 (aHBe2) – Atellica IM – RGT 50T
Siemens Healthcare Diagnostics Inc.
10733021
In Commercial Distribution

  • 00842768022678 ()
10733021

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

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 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 HBsAg Immunoassay - 04015630911073

No Description
Roche Diagnostics GmbH
11820532160
In Commercial Distribution

  • 04015630911073 ()
11820532160

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

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 PreciControl HBsAg - 04015630911059

No Description
Roche Diagnostics GmbH
11876309160
Not in Commercial Distribution

  • 04015630911059 ()
11876309160

  • Hepatitis B virus surface 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
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