Aniara Diagnostica, LLC
Aniara Diagnostica, LLC holds FDA 510(k) medical device clearance, cleared in 2009, with 11 FDA device recalls on record.
Top product codes for Aniara Diagnostica, LLC
FDA recalls by Aniara Diagnostica, LLC
10 most recent of 11- Z-2894-2026 — 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- Z-2895-2026 — 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
- Z-2896-2026 — 5-PLASMA Bivalirudin Control, Model Number 5D-44905
- Z-2171-2026 — ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
- Z-1227-2023 — BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen.
- Z-1743-2022 — BIOPHEN UFH Control Plasma
- Z-2347-2019 — ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
- Z-2346-2019 — ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
- Z-1190-2019 — BIOPHEN LMWH Control C4, REF 224201
- Z-1189-2019 — BIOPHEN UFH Control C1, REF 224101
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 Aniara Diagnostica, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.