Device Recall SickleScan

  • 모델명 / 제조번호(시리얼번호)
    Lot# 1187, expiration date: 7/13  Catalog No.13-2101, Powder Lot # 1171 (part of kit)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C, Distributed by True-Medix Diagnostic Brooklyn, NY 11228, 800-952-3349. || For the qualitative determination Hemoglobin S, 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