Diagnostica Stago, Inc.
Diagnostica Stago, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2026, with 27 FDA device recalls on record.
Top product codes for Diagnostica Stago, Inc.
FDA recalls by Diagnostica Stago, Inc.
10 most recent of 27- Z-3047-2026 — STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
- Z-1585-2026 — Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
- Z-1491-2026 — Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable
- Z-1084-2026 — Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
- Z-0205-2026 — Product: STA Liatest D-Di; REF: 00515;
- Z-2475-2025 — STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
- Z-2476-2025 — STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.
- Z-2474-2025 — STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
- Z-2473-2025 — STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
- Z-1993-2025 — STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
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 Diagnostica Stago, Inc.
- K253658 — STA Satellite Max®
- K120014 — STA- COAG CONTROL (N+ABN) PLUS
- K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
- K092937 — STA-HYBRID HEP CALIBRATOR
- K092170 — STA LIATEST FREE PS
- K093167 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
- K092113 — STA - FREE PS CALIBRATOR
- K082248 — STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
- K082675 — STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
- K061805 — STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
- K061803 — STA - CONTROL LA 1+2
- K053111 — STA-CEPHASCREEN KIT
- K010963 — STA-LIATEST FREE PROTEIN S TEST KIT
- K010324 — STA-QUALITY HBPM/LMWH KIT
- K010350 — STA -CALIBRATOR HBPM/LMWH KIT
- K003767 — ASSERACHROM HPIA TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.