SENTINEL CH. SpA
SENTINEL CH. SpA holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2025, with 8 FDA device recalls on record.
Top product codes for SENTINEL CH. SpA
FDA recalls by SENTINEL CH. SpA
- Z-0325-2024 — IRON assay, Reference Numbers 6K95-41 and 6K95-30
- Z-0326-2024 — Alinity c Iron Reagent, Reference Number 08P3920
- Z-0033-2022 — Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
- Z-2012-2021 — ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
- Z-2552-2019 — Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320
- Z-2551-2019 — MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
- Z-2867-2017 — MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2
- Z-0164-2016 — Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by SENTINEL CH. SpA
- K242585 — Cystatin C
- K211058 — Lp(a) Ultra
- K193001 — Albumin BCP
- K192118 — CRP Vario
- K173833 — CRP Vario
- K141728 — ACE CALIBRATOR
- K102706 — CKMB UDR ASSAY
- K083602 — KAPPA LIGHT CHAINS
- K083601 — LAMBDA LIGHT CHAINS
- K081533 — SENTINEL PLASMAPROTEINS CAL 3X
- K073634 — MULTIGENT CREATININE (ENZYMATIC) ASSAY
- K070987 — SENTINEL LITHIUM ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.