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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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Atellica IM aHBcM - 00630414301266

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

IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC - 00630414978017

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

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

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

IMMULITE®/IMMULITE®1000 Systems aBC Anti-HBc - 00630414970974

aBC Anti-HBc Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370305
Not in Commercial Distribution

  • 00630414970974 ()
LKHC1(D)

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

IMMULITE®1000 System ID4 ID4 Sample Diluent - 00630414960975

ID4 Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381266
In Commercial Distribution

  • 00630414960975 ()
  • 00630414601748 ()
L1KMCW1

  • Buffered sample diluent IVD
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