Device Recall Tosoh ST AIAPACK HbA1c

  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • 제품 설명
    Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 || The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • 제품 설명
    Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 || The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • 제품 설명
    Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 || The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
  • 유통
    USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • 제품 설명
    Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 || The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
  • Manufacturer