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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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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 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373676
In Commercial Distribution

  • 00630414978017 ()
L2MCCVM

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
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
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
No Description
Roche Diagnostics GmbH
11876333160
In Commercial Distribution

11876333160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
No Description
Roche Diagnostics GmbH
11820567160
In Commercial Distribution

11820567160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876376160
In Commercial Distribution

11876376160

  • Hepatitis B virus e-antigen IVD, control
No Description
Roche Diagnostics GmbH
11820583160
In Commercial Distribution

11820583160

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08343594160
In Commercial Distribution

  • 07613336154014 ()
08343594160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
04927931161
In Commercial Distribution

  • 07613336153949 ()
04927931161

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
07026811160
In Commercial Distribution

  • 07613336153932 ()
07026811160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07026790160
Not in Commercial Distribution

  • 07613336153925 ()
07026790160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07374160160
Not in Commercial Distribution

  • 07613336142295 ()
07374160160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08498610160
In Commercial Distribution

  • 07613336230367 ()
08498610160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08814856160
In Commercial Distribution

  • 07613336198285 ()
08814856160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08814864160
Not in Commercial Distribution

  • 07613336198278 ()
08814864160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08741034190
In Commercial Distribution

  • 07613336172902 ()
08741034190

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08814848190
In Commercial Distribution

  • 07613336168103 ()
08814848190

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08498598160
In Commercial Distribution

  • 07613336160367 ()
08498598160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs CC 3 Elecsys
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution

  • 07613336159804 ()
04985354160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
09014926160
In Commercial Distribution

  • 07613336203613 ()
09014926160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
09014918160
In Commercial Distribution

  • 07613336203606 ()
09014918160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08741107190
In Commercial Distribution

  • 07613336164372 ()
08741107190

  • Hepatitis B virus surface antigen IVD, control
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