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
Calprest — EUROSPITAL SPAALPCO Calprotectin Immunoturbidimetric Assay — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.Fecal Extraction Device — INOVA DIAGNOSTICS, INC.LIAISON Q.S.E.T. Device Plus — Diasorin Inc.QUANTA Flash Calprotectin Extraction Buffer — INOVA DIAGNOSTICS, INC.ALPCO Calprotectin Chemiluminescence ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.BÜHLMANN fCAL® turbo Reagent Kit — Bühlmann Laboratories AGCalprest NG — EUROSPITAL SPAALPCO Calprotectin Chemiluminescence ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.fCAL turbo — Bühlmann Laboratories AGQUANTA Lite® Calprotectin ELISA — INOVA DIAGNOSTICS, INC.ALPCO Calprotectin Immunoturbidimetric Assay — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.EasyCal — EUROSPITAL SPABÜHLMANN fCAL® ELISA — Bühlmann Laboratories AGQUANTA LITE®Calprotectin Extended Range — INOVA DIAGNOSTICS, INC.PhiCal Test — EUROSPITAL SPACalprotectin Immunoturbidimetric Assay - Calibrators — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ALPCO Calprotectin Immunoturbidimetric Assay — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.QUANTA Flash® Calprotectin Reagents — INOVA DIAGNOSTICS, INC.BÜHLMANN fCAL® turbo Reagent Kit — Bühlmann Laboratories AG
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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