DeviceClearance

Product code NIY— Immunology

EUROIMMUN ANTI-SLA/LP ELISA(LGG)

Classification name
Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

FDA classification definition

“ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis”

— U.S. Food and Drug Administration, device classification record for product code NIY under 21 CFR 866.5660, via openFDA

Market context for product code NIY

FDA has cleared 3 devices under product code NIY between 2002 and 2013, filed by 2 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 NIY

Recent clearances under product code NIY

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