DeviceClearance

Product code NQD— Immunology

ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS

Classification name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Device class
Class 2
Regulation
21 CFR 866.5270
Advisory panel
Immunology
Total cleared
19
First cleared
Most recent

FDA classification definition

“In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.”

— U.S. Food and Drug Administration, device classification record for product code NQD under 21 CFR 866.5270, via openFDA

Market context for product code NQD

FDA has cleared 19 devices under product code NQD between 2004 and 2026, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NQD

Recent clearances under product code NQD

Data sourced from openFDA. This site is unofficial and independent of the FDA.