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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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PATHFAST - 04987595300646

No Description
PHC CORPORATION
N/A
In Commercial Distribution

  • 04987595300646 ()
  • 14987595300643 ()
300646

  • Chemiluminescent immunoassay analyser IVD

Automated Blood Coagulation Analyzer CA-600 series CA-660 - 04987562518685

a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use.
SYSMEX CORPORATION
CK978289
In Commercial Distribution

  • 04987562518685 ()


  • Coagulation analyser IVD, laboratory

Automated Blood Coagulation Analyzer CA-600 series CA-620 - 04987562518678

A fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use
SYSMEX CORPORATION
BR142626
In Commercial Distribution

  • 04987562518678 ()


  • Coagulation analyser IVD, laboratory

Automated Blood Coagulation Analyzer CS-2500 - 04987562518661

A fully automated blood coagulation analyzer intended for in vitro diagnostic use.
SYSMEX CORPORATION
BV981798
In Commercial Distribution

  • 04987562518661 ()


  • Coagulation analyser IVD, laboratory

Automated Blood Coagulation Analyzer CS-5100 - 04987562518654

A fully automated blood coagulation analyzer intended for in vitro diagnostic use.
SYSMEX CORPORATION
BY990757
In Commercial Distribution

  • 04987562518654 ()


  • Coagulation analyser IVD, laboratory

CA CAL S - 04987562516797

The product is applied to calibrate the sensitivity of LEDs used for blood coagulation analyzer.
SYSMEX CORPORATION
014-1271-4
In Commercial Distribution

  • 14987562516794 ()
  • 04987562516797 ()


  • Multiple coagulation factor IVD, calibrator

Sample Preparation System PS-10 - 04987562501908

The Sample Preparation System PS-10 is a fully automated, user-configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
SYSMEX CORPORATION
PS-10
In Commercial Distribution

  • 04987562501908 ()


  • Pipetting system IVD

LYSERCELL WDF - 04987562499809

Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF
SYSMEX CORPORATION
AZ124801
In Commercial Distribution

  • 04987562499809 ()

  • Total Volume: 2 Liter


  • Blood cell lysis reagent IVD

Automated Blood Coagulation Analyzer CS-2500 - 04987562433735

CS-2500 COMPLETE
SYSMEX CORPORATION
BV981798
In Commercial Distribution

  • 04987562433735 ()


  • Coagulation analyser IVD, laboratory

ENDOPRO STANDALONEC CAPTURE WORKSTATION - 04961333248025

ENDOPRO CAPTURE WORKSTATION, STANDALONE
PENTAX OF AMERICA, INC.
KBM68346
In Commercial Distribution

  • 04961333248025 ()


  • Medical image management system
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