Werfen Australia Pty Ltd

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 4 건

  • 모델명 / 제조번호(시리얼번호)
    HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD)Part Number: 0008469810Affected Lot Numbers: N1222324, N0333626, N0735317 and N0148094.
  • 의료기기 분류등급
  • 모델명 / 제조번호(시리얼번호)
    ACL Top Family of instruments (haemostasis testing systems). An in vitro diagnostic medical device (IVD). ACL TOP Part Number: 00000280000 ACL TOP CTS Part Number: 00000280020 ACL TOP 700 Part Number: 00000280010 ACL TOP 700 CTS Part Number: 00000280050 ACL TOP 700 LAS Part Number: 00000280030 ACL TOP 500 CTS Part Number: 00000280040 ACL TOP 300 CTS Part Number: 00000280060
  • 의료기기 분류등급
  • 모델명 / 제조번호(시리얼번호)
    ACL Top Family of analysers used with HemosIL APTT reagent (an in vitro diagnostic medical device (IVD))Models affected: ACL TOP, ACL TOP CTS, ACL TOP 700, ACl TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS and ACL TOP 300 CTSPart Numbers: 00000280000, 00000280010, 00000280020, 00000280030, 00000280040, 00000280050 and 00000280060ARTG Number: 197892, 98770
  • 모델명 / 제조번호(시리얼번호)
    ACL ELITE, ACL ELITE PRO, ACL 8000, ACL 9000 and ACL 10000 (coagulation analysers)