Manufacturers

Polymer Technology Systems, Inc.

9 devices in the database

Device Recall CardioChek PTS Panels CHOLHDLGLU
  • Model / Serial
    Lot number I904
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.
  • Product Description
    PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.
Device Recall PTS Panels Lipids Panel test strips
  • Model / Serial
    Lot P814; exp. 9/2/09.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and international.
  • Product Description
    PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.
Device Recall PTS Panels CHOLHDL Panel test strips
  • Model / Serial
    Lot G751.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. || The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.
Device Recall PTS Panels LDL Cholesterol test strips
  • Model / Serial
    Lots L771, exp. 12/04/08 and L781, exp. 12/17/2008.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution
  • Product Description
    PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. || For the quantitative measurement of LDL cholesterol in whole blood.
Device Recall PTS Panels Creatinine test strips.
  • Model / Serial
    Cat No. 1720; and Lot number F103
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
  • Product Description
    PTS Panels Creatinine test strips. || PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
4 more

2 manufacturers with a similar name

Learn more about the data here

Polymer Technology Systems, Inc.
Mex Global Equipamentos para Diagnósticos Ltda; Polymer Technology Systems, Inc.
  • Source
    ANVSANVISA