Manufacturers

Polymer Technology Systems, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 9 건

Device Recall CardioChek PTS Panels CHOLHDLGLU
  • 모델명 / 제조번호(시리얼번호)
    Lot number I904
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Lot P814; exp. 9/2/09.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and international.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Lot G751.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Lots L771, exp. 12/04/08 and L781, exp. 12/17/2008.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution
  • 제품 설명
    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.
  • 모델명 / 제조번호(시리얼번호)
    Cat No. 1720; and Lot number F103
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
  • 제품 설명
    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
하나 더 4 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

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