Calcium Arsenazo, CALA0250

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers distributed in the US:  Lot 11-2614, Expiration 07/2013. Lot 12-1002; Expiration 03/2014. Lot 12-2220, Expiration 08/2014.  Lot numbers distributed in Sweden: 11-2129, 12-2616, 11-2769, 12-2975, 10-3036, 10-0454, 10-1874, 11-0176, 11-1248, 11-1690, 12-0140, 12-0938, 12-1383, 13-0004, and 13-0408
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including the states of KY and UT and the country of Sweden.
  • 제품 설명
    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. || The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. || The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . || CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    SEPPIM SAS, ZONE INDUSTRIELLE, SEES France
  • Source
    USFDA