NIY · Class II · 21 CFR 866.5660

FDA Product Code NIY: Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis

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

Leading manufacturers include Euroimmun US and Inova Diagnostics, Inc..

3
Total
3
Cleared
332d
Avg days
2002
Since

FDA 510(k) Cleared Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis Devices (Product Code NIY)

3 devices
1–3 of 3
Cleared Apr 12, 2013
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
K113439
Euroimmun US
Immunology · 508d
Cleared Sep 11, 2012
EUROIMMUN ANTI-SLA/LP ELISA(LGG)
K112221
Euroimmun US
Immunology · 406d
Cleared Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
K021482
Inova Diagnostics, Inc.
Immunology · 83d

About Product Code NIY - Regulatory Context