MULTIGENT Creatinine (Enzymatic)

  • 모델명 / 제조번호(시리얼번호)
    List number : 8L24-31 Lot Number : 60335Y600, 60382Y600 UDI Number : (01)00380740017682(17)180228, (10)60335Y600(240)8L2431, (01)00380740017682(17)180228, (10)60382Y600(240)8L2431 List Number : 8L24-41 Lot Number : 60334Y600 UDI number : 01)00380740017699(17)180228, (10)60334Y600(240)8L2441
  • 제품 설명
    List number : 8L24-31
  • Manufacturer
  • 1 Event

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • 제조사 대표
    Abbott Diagnostics Division
  • Source
    SFDA

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  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28); Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems || The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lots 60335Y600, 60382Y600 and lot 60334Y600
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    In-vitro diagnostic products
  • Manufacturer
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