Devices

Device Recall TREPCHEK

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 71303, expiration date June 2004
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to three hospitals/clinics in AZ, CA and TX.
  • 제품 설명
    Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127
  • Manufacturer
    Diamedix Corporation
  • 1 Event

제조사

Diamedix Corporation
  • 제조사 주소
    Diamedix Corporation, 2140 N Miami Ave, Miami FL 33127-4916
  • Source
    USFDA

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

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Device Recall TrepChek Syphilis Test Kit
  • 모델명 / 제조번호(시리얼번호)
    lot # 041207T expiration date 9-30-2005
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    MA, CA, TX, KS, NY, FL
  • 제품 설명
    Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.
  • Manufacturer
    Diasorin Inc.