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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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Tinaquant Apolipoprotein AI ver2 - 04015630930227

No Description
Roche Diagnostics GmbH
6301703190
In Commercial Distribution

  • 04015630930227 ()
6301703190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Tinaquant Apolipoprotein A1 ver2 - 04015630928651

No Description
Roche Diagnostics GmbH
5950686190
In Commercial Distribution

  • 04015630928651 ()
5950686190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Synchron - 15099590229931

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 - 15099590223878

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

AU - 15099590010393

APO A1
Beckman Coulter, Inc.
OSR6142
In Commercial Distribution

  • 15099590010393 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

VITROS - 10758750006700

VITROS Chemistry Products Calibrator Kit 22
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801706
In Commercial Distribution

  • 10758750006700 ()
6801706

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

Medline Industries, Inc. - 10193489947168

HEART AI VASCULAR TRAY
MEDLINE INDUSTRIES, INC.
DYNJ69470
In Commercial Distribution

  • 10193489947168 ()
  • 40193489947169 ()
DYNJ69470

  • General surgical procedure kit, non-medicated, single-use

TRITON - 00859506006081

Triton AI Calibration Placard
STRYKER CORPORATION
FG-12008
In Commercial Distribution

  • 00859506006081 ()
  • 10859506006088 ()
FG-12008

  • Blood loss estimation canister insert/label

Caption - 00198953030233

Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software

K-ASSAY® Apo AI Reagent - 00816426020016

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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