LKJ · Class II · 21 CFR 866.5100

FDA Product Code LKJ: Antinuclear Antibody, Antigen, Control

Leading manufacturers include Bio-Rad, Zeus Scientific, Inc. and Elias U.S.A., Inc..

50
Total
50
Cleared
88d
Avg days
1983
Since
50 devices
25–48 of 50
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Nov 04, 1987
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115
Sigma Diagnostics, Inc.
Immunology · 26d
Cleared Aug 06, 1986
KALLESTAD SM/RNP TEST REAGENT
K862313
Kallestad Laboratories, Inc.
Immunology · 49d