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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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Roche Diagnostics GmbH
6301703190
In Commercial Distribution

  • 04015630930227 ()
6301703190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
5950686190
In Commercial Distribution

  • 04015630928651 ()
5950686190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Apolipoprotein A Reagent (ApoA 2 x 100)
Beckman Coulter, Inc.
467900
In Commercial Distribution

  • 15099590229931 ()
467900

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent
Beckman Coulter, Inc.
446410
In Commercial Distribution

  • 15099590223878 ()
446410

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
APO A1
Beckman Coulter, Inc.
OSR6142
In Commercial Distribution

  • 15099590010393 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
VITROS Chemistry Products Calibrator Kit 22
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801706
In Commercial Distribution

  • 10758750006700 ()
6801706

  • Apolipoprotein A-I (Apo A1) IVD, calibrator
HEART AI VASCULAR TRAY
MEDLINE INDUSTRIES, INC.
DYNJ69470
In Commercial Distribution

  • 10193489947168 ()
  • 40193489947169 ()
DYNJ69470

  • General surgical procedure kit, non-medicated, single-use
Triton AI Calibration Placard
STRYKER CORPORATION
FG-12008
In Commercial Distribution

  • 00859506006081 ()
  • 10859506006088 ()
FG-12008

  • Blood loss estimation canister insert/label
Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software
For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-002
In Commercial Distribution

  • 00816426020016 ()
KAI-002

  • Apolipoprotein A-I (Apo A1) IVD, reagent
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