Device Recall Sickle Heme

  • 모델명 / 제조번호(시리얼번호)
    Lot# 1187, expiration date: 7/13  Catalog No.MCA-IOO, MHK 110A Powder Lot # 1171 (part of kit)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powder; One Line Scale Two Dispensing Closures; For Invitor Diagnostics Use, Store at Room Temperature, Michclone Associates, Madison Heights, MI 48071. || For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    MichClone Associates, Inc., 680 Ajax Drive, Madison Heights MI 48071-2414
  • Source
    USFDA