Home › Device types › NXO
Calprotectin, Fecal
FDA product code NXO · Class 2 · Immunology
20
Registered devices
1
Adverse events
3
Recalls
15
510(k) clearances
Devices with this code
QUANTA Flash Calprotectin Extraction Buffer — INOVA DIAGNOSTICS, INC.EasyCal — EUROSPITAL SPAPhiCal Test — EUROSPITAL SPACalprest — EUROSPITAL SPABÜHLMANN fCAL® turbo Reagent Kit — Bühlmann Laboratories AGFecal Extraction Device — INOVA DIAGNOSTICS, INC.ALPCO Calprotectin Chemiluminescence ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.BÜHLMANN fCAL® ELISA — Bühlmann Laboratories AGQUANTA Flash® Calprotectin Reagents — INOVA DIAGNOSTICS, INC.BÜHLMANN fCAL® turbo Reagent Kit — Bühlmann Laboratories AGALPCO Calprotectin Immunoturbidimetric Assay — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ALPCO Calprotectin Immunoturbidimetric Assay — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.QUANTA LITE®Calprotectin Extended Range — INOVA DIAGNOSTICS, INC.QUANTA Lite® Calprotectin ELISA — INOVA DIAGNOSTICS, INC.Calprotectin Immunoturbidimetric Assay - Calibrators — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ALPCO Calprotectin Immunoturbidimetric Assay — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.fCAL turbo — Bühlmann Laboratories AGALPCO Calprotectin Chemiluminescence ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.Calprest NG — EUROSPITAL SPALIAISON Q.S.E.T. Device Plus — Diasorin Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-11-07 | Diasorin Inc. | Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISO |
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