Catch Incorporated

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 2 건

  • 모델명 / 제조번호(시리얼번호)
    Catch Inc. - Lot Numbers and expiration dates include L05037 2007-05, B06003 2007-08, F06011 2007-12 and H06021 200802. Equal Diagnostics -Lot Number and expiration date include F06011 2007-12. First digit is the month of manufacture, A = Jan, B = Feb, but I is not used. Second and third digits are the year of manufacture, 05 = 2005. The remaining digits are sequential numbers for the next lot.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA and PA.
  • 제품 설명
    Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, Manufactured at Intersect Systems, Inc., Longview, WA 98632". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL). The second brand name Equal the label reads "EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, Equal Diagnostic, Exton, PA 19341". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma.
  • 모델명 / 제조번호(시리얼번호)
    Lot D1101303
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product distributed in PA.
  • 제품 설명
    Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. || A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.