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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 AF AFP - 00630414961033

AF AFP Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381187
In Commercial Distribution

  • 00630414961033 ()
L2KAP2

  • Alpha-fetoprotein (AFP) 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

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® 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® 2000 Systems AF AFP - 00630414961040

AF AFP Kit 600 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381184
In Commercial Distribution

  • 00630414961040 ()
L2KAP6

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems aHBs2 QC - 00630414551777

Anti-HBs2 (aHBs2) Quality Control Material
Siemens Healthcare Diagnostics Inc.
10283088
In Commercial Distribution

  • 00630414551777 ()
6521435

  • Hepatitis B virus surface total antibody IVD, control
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