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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 HBcT2 (REF) 500T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11643118
In Commercial Distribution

  • 00630414637877 ()
11643118

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200740
In Commercial Distribution

  • 00630414604336 ()
11200740

  • Hepatitis B virus core total antibody IVD, control
HBc Total 2 (HBcT2) Atellica IM - RGT 100T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200739
In Commercial Distribution

  • 00630414604138 ()
11200739

  • Hepatitis B virus core total 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
The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture.
Oxford Immunotec, Inc.
TSK.910
In Commercial Distribution

  • 05051716000186 ()
TSK.910US

  • T lymphocyte magnetic separation reagent IVD
STENT PED3-027-400-16 V03 VANTAGE
Micro Therapeutics, Inc.
PED3-027-400-16
In Commercial Distribution

  • 00847536036703 ()


  • Bare-metal intracranial vascular stent
STENT PED3-027-400-14 V03 VANTAGE
Micro Therapeutics, Inc.
PED3-027-400-14
In Commercial Distribution

  • 00847536036697 ()


  • Bare-metal intracranial vascular stent
STENT PED3-027-400-12 V03 VANTAGE
Micro Therapeutics, Inc.
PED3-027-400-12
In Commercial Distribution

  • 00847536036680 ()


  • Bare-metal intracranial vascular stent
STENT PED3-027-350-35 V03 VANTAGE
Micro Therapeutics, Inc.
PED3-027-350-35
In Commercial Distribution

  • 00847536036666 ()


  • Bare-metal intracranial vascular stent
STENT PED3-027-350-25 V03 VANTAGE
Micro Therapeutics, Inc.
PED3-027-350-25
In Commercial Distribution

  • 00847536036642 ()


  • Bare-metal intracranial vascular stent
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