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Test, Cystatin C
FDA product code NDY · Class 2 · Clinical Chemistry
35
Registered devices
21
Adverse events
4
Recalls
22
510(k) clearances
Devices with this code
Gentian Cystatin C Control Kit (2 x 1mL) — Gentian ASDako — AGILENT TECHNOLOGIES SINGAPORE PTE LTDDako — AGILENT TECHNOLOGIES SINGAPORE PTE LTDADVIA Chemistry Cystatin C_2 Assay — Siemens Healthcare Diagnostics Inc.Gentian Cystatin C Reagent for the Beckman Coulter AU Systems (1x300) — Gentian ASN Latex Cystatin C — Siemens Healthcare Diagnostics Products GmbHAtellica™ CH CysC — Siemens Healthcare Diagnostics Inc.Tina-quant Cystatin C Gen.2 — Roche Diagnostics GmbHN Latex Cystatin C — Siemens Healthcare Diagnostics Products GmbHGentian Cystatin C Control Kit (2 x 5mL) — Gentian ASGentian Cystatin C Single Use Control High — Gentian ASDImension Vista® Cystatin C Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHCYSC — RANDOX LABORATORIES LIMITEDK-ASSAY® Cystatin C Reagent — KAMIYA BIOMEDICAL COMPANY, LLCGentian Cystatin C Control Kit (2 x 1mL) — Gentian ASGentian Cystatin C Calibrator Kit — Gentian ASK-ASSAY® Cystatin C Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLCST AIA-PACK Cyctatin C Sample Dilting Solution — TOSOH CORPORATIONGentian Cystatin C Calibrator — Gentian ASGentian Cystatin C Calibrator Kit — Gentian ASTina-quant Cystatin C Gen.2 — Roche Diagnostics GmbHTina-quant Cystatin C Gen.2 — Roche Diagnostics GmbHGentian Cystatin C Reagent Kit — Gentian ASOptilite Cystatin C Kit — THE BINDING SITE GROUP LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-07 | Randox Laboratories Ltd. | Cystatin C Reagent marketed without a 510 (k) |
| 2024-02-14 | Randox Laboratories Ltd. | Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods |
| 2020-09-02 | Gentian AS | The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distrib |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
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