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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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ADVIA Centaur® Systems, ACS:180® Systems Calibrator Q - 00630414202921

Calibrator Q - 6 pack (PSA Cal)
Siemens Healthcare Diagnostics Inc.
10310296
In Commercial Distribution

  • 00630414202921 ()
118221

  • Total prostate specific antigen (tPSA) IVD, calibrator

ADVIA Centaur® AFP - 00630414177335

Alpha-Fetoprotein (AFP) Assay Kit (5-pack) 500T
Siemens Healthcare Diagnostics Inc.
10309980
In Commercial Distribution

  • 00630414177335 ()
  • 00630414601724 ()
110764

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

ADVIA Centaur® AFP - 00630414177328

Alpha-Fetoprotein (AFP) Assay Kit (1-pack) 100T
Siemens Healthcare Diagnostics Inc.
10309979
In Commercial Distribution

  • 00630414177328 ()
110763

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

ADVIA Centaur aHBe2 50T Kit - 00630414167923

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

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® 2000 Systems fPS Free PSA - 00630414977478

fPS Free PSA Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10487239
In Commercial Distribution

  • 00630414977478 ()
L2KPF2(D)

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems, ACS:180® Systems Calibrator D - 00630414124940

Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10331182
In Commercial Distribution

  • 00630414124940 ()
672183005

  • Multiple tissue-associated protein/tumour marker IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems Calibrator D - 00630414124933

Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311576
In Commercial Distribution

  • 00630414124933 ()
672183000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
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