免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

Fujirebio Diagnostics,Inc.

FDA 510(k) & PMA Approved 器材 — 17 products

器材總數17
類別0
最新 FDA 裁決
類型編號器材名稱代碼日期操作
510(k) K250925 ADVIA Centaur 維甲酸片段 21-1OVK2025-12-16 查看
510(k) K242706 Lumipulse G pTau217/β-Amyloid 1-42 血漿比值SET2025-05-16 查看
510(k) K192524 Lumipulse G CA15-3MOI2020-09-04 查看
510(k) K192380 ST AIA-PACK BNPNBC2020-08-24 查看
510(k) K200997 Lumipulse G CA19-9-NNIG2020-05-14 查看
510(k) K190702 Lumipulse G whole PTHCEW2019-08-30 查看
510(k) K172713 Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setPRI2017-12-10 查看
510(k) K171103 Lumipulse G TSH-III Immunoreaction CartridgesJLW2017-07-28 查看
510(k) K163546 Lumipulse G Progesterone-N CalibratorsJIT2017-01-13 查看
510(k) K163534 Lumipulse G FSH-N CalibratorsJIT2017-01-13 查看
510(k) K163544 Lumipulse G ProlactinJIT2017-01-12 查看
510(k) K163521 Lumipulse G LH CalibratorsJIT2017-01-12 查看
510(k) K163053 Lumipulse G E2-III CalibratorsJIT2016-12-01 查看
510(k) K153145 Lumipulse G TP-N Immunoreaction Cartridge SetLIP2016-07-05 查看
510(k) K160090 Lumipulse G ROMAONX2016-05-16 查看
510(k) K151502 ARCHITECT ROMAONX2016-04-28 查看
510(k) K153361 Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsMRG2016-04-15 查看
↑