Product code NJF— Immunology

QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA

Classification name: Antibodies, Anti-Actin, Anti-Smooth Muscle
Device class: Class 2
Regulation: 21 CFR 866.5120
Advisory panel: Immunology
Total cleared: 1
First cleared: 2002-09-20
Most recent: 2002-09-20

FDA classification definition

“The device is used for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.”
— U.S. Food and Drug Administration, device classification record for product code NJF under 21 CFR 866.5120, via openFDA

Market context for product code NJF

FDA has cleared 1 device under product code NJF, all in 2002, 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 NJF

Inova Diagnostics, Inc.1 clearance

Recent clearances under product code NJF

K021648 — QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISAInova Diagnostics, Inc.·2002-09-20

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