Taiwan FDA registration d268726a854717fc4290160c3ef09c0d

BD OneFlow 漿細胞檢驗試劑

Taiwan·Risk Class 2·Becton, Dickinson and Company, BD Biosciences;; Becton, Dickinson Caribe, Ltd.·Registered May 23, 2024 – May 23, 2029Active

Registration details

Analysis ID: d268726a854717fc4290160c3ef09c0d
Customs Code: DHA05603707906

Company information

Manufacturer: Becton, Dickinson and Company, BD Biosciences;; Becton, Dickinson Caribe, Ltd.
Manufacturer Country: United States
Authorized Representative: BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE)

Product details

Intended Use: The OneFlow Plasma Cell Disease Test is used as a diagnostic aid to differentiate between patients with hematologic abnormalities and suspected plasma cell disorders. The OneFlow Plasma Cell Disease Test can be used with collected EDTA or bone marrow specimens from heparin tubes. Results must be interpreted by a pathologist or equivalent professional in conjunction with other clinical or laboratory findings.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5220 Automatic Differentiation Cell Counter
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: May 23, 2024
Expiry Date: May 23, 2029

About this record

Access comprehensive regulatory information for BD OneFlow 漿細胞檢驗試劑 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d268726a854717fc4290160c3ef09c0d and manufactured by Becton, Dickinson and Company, BD Biosciences;; Becton, Dickinson Caribe, Ltd.. The authorized representative in Taiwan is BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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