Device Recall STA System Control NP

  • 모델명 / 제조번호(시리얼번호)
    K9483518 D029396 Lot #106775
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution and USA (Nationwide) and including Canada
  • 제품 설명
    STA - System Control N + P || Product Usage: || The STA¿ -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STA¿brand name suitable to these reagents: -the Reagent 1 (STA¿-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase¿¿ time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA¿¿ -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase¿¿ time. Do not use the STA¿¿ -System Control N+P kit on STA Satellite¿ for the control of the APTT performed with the STA¿¿-rTT kit.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Diagnostica Stago, Inc., 5 Century Dr, Parsippany NJ 07054-4607
  • Source
    USFDA