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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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Alinity i Anti-HBc Calibrator
Abbott GmbH
07P8401
In Commercial Distribution

  • 00380740136635 ()
07P8401

  • Hepatitis B virus core total antibody IVD, calibrator
Alinity i HBsAg Qualitative II Reagent Kit 200 Tests
Abbott Ireland Diagnostics
08P1021
In Commercial Distribution

  • 00380740136581 ()
08P1021

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10464359
In Commercial Distribution

  • 00842768024214 ()
KC602

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Free Prostate Specific Antigen Flex® reagent cartridge 80 Test
Siemens Healthcare Diagnostics Inc.
10445091
In Commercial Distribution

  • 00842768016677 ()
  • 00630414601786 ()
K6452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10445090
In Commercial Distribution

  • 00842768016660 ()
  • 00630414601779 ()
K6451

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444888
In Commercial Distribution

  • 00842768013881 ()
  • 00630414601755 ()
RF452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA)
Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444889
In Commercial Distribution

  • 00842768013874 ()
  • 00630414601762 ()
RF451

  • Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)
Heterogeneous Immunoassay Module Total/Free Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10445031
In Commercial Distribution

  • 00842768013751 ()
RC452

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Beckman Coulter, Inc.
33211
In Commercial Distribution

  • H628332111 ()
33211

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay
injectable (hyaluronic acid, intra-articular)
FCL HEALTH SOLUTIONS LTD
None
In Commercial Distribution

  • 35060432190003 ()


  • Synovial fluid supplementation medium
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