Fujirebio Diagnostics,Inc.
FDA 510(k) medical device clearances.
Top product codes for Fujirebio Diagnostics,Inc.
Recent clearances by Fujirebio Diagnostics,Inc.
- K250925 — ADVIA Centaur Cytokeratin Fragment 21-1
- K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
- DEN200072 — Lumipulse G ß-Amyloid Ratio (1-42/1-40)
- K192524 — Lumipulse G CA15-3
- K192380 — ST AIA-PACK BNP
- K200997 — Lumipulse G CA19-9-N
- K190702 — Lumipulse G whole PTH
- K172713 — Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set
- K171103 — Lumipulse G TSH-III Immunoreaction Cartridges
- K163534 — Lumipulse G FSH-N Calibrators
- K163546 — Lumipulse G Progesterone-N Calibrators
- K163521 — Lumipulse G LH Calibrators
- K163544 — Lumipulse G Prolactin
- K163053 — Lumipulse G E2-III Calibrators
- K153145 — Lumipulse G TP-N Immunoreaction Cartridge Set
- K160090 — Lumipulse G ROMA
- K151502 — ARCHITECT ROMA
- K153361 — Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
- K151378 — Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
- K142895 — LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
- K140436 — ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
- K133197 — FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
- K123612 — FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
- K103358 — ROMA (HE4 EIA + ARCHITECT CA 125 II)
- K103676 — FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
- K110641 — FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
- K100831 — CYFRA 21-1 EIA MODEL 211-10
- K110436 — FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
- K103450 — FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
- K101809 — FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
- K102260 — FDI GLUCOSE CONTROL SOLUTIONS
- K093957 — ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- K092645 — FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
- K080751 — ARCHITECT CYCLOSPORINE
- K072939 — HE4 EIA, MODEL: 404-10 US
- K070822 — ARCHITECT SIROLIMUS ASSAY
- K070820 — ARCHITECT TACROLIMUS: MODEL 1L77
- K060964 — ARCHITECT BNP ASSAY, MODEL 8K28
- K052889 — VITROS CA 19-9
- K052000 — ARCHITECT CA 19-9XR ASSAY
- K042732 — ARCHITECT CA 15-3 ASSAY
- K042731 — ARCHITECT CA 125 II ASSAY
- K033731 — AXSYM CORTISOL ASSAY
- K020566 — FUJIREBIO DIAGNOSTICS CA 19-9 RIA
- K893124 — OLYMPUS PK(TM) TP
Data sourced from openFDA. This site is unofficial and independent of the FDA.