DeviceClearance

Product code NUM— Immunology

QUANTA LITE SP100 ELISA

Classification name
Autoantibodies, Nuclear Body Protein, Sp100
Device class
Class 2
Regulation
21 CFR 866.5090
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

“THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.”

— U.S. Food and Drug Administration, device classification record for product code NUM under 21 CFR 866.5090, via openFDA

Market context for product code NUM

FDA has cleared 1 device under product code NUM, all in 2005, filed by 1 applicant company. 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.

Top applicants under product code NUM

Recent clearances under product code NUM

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