LKJ · Class II · 21 CFR 866.5100

FDA Product Code LKJ: Antinuclear Antibody, Antigen, Control

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

50
Total
50
Cleared
88d
Avg days
1983
Since
50 devices
25–48 of 50
Cleared Aug 23, 1993
SYLNELISA HISTONE ANTIBODIES
K932302
Elias U.S.A., Inc.
Immunology · 103d
Cleared Dec 01, 1992
SYN ELISA DSDNA ANTIBODIES
K921132
Elias U.S.A., Inc.
Immunology · 266d
Cleared May 22, 1992
THE THERATEST EL-ANA PROFILES
K914454
Theratest Laboratories, Inc.
Immunology · 228d
Cleared May 01, 1992
AUTOSTAT(TM) ANTI-DSNA
K913342
Cogent Diagnotics , Ltd.
Immunology · 280d
Cleared Jul 30, 1991
DISTAT ANTI-SCL-70 KIT
K912291
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Aug 02, 1989
SERATEST ENA [SCL-70] KIT
K894411
Hemagen Diagnostics, Inc.
Immunology · 16d
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883
Immco Diagnostics, Inc.
Immunology · 44d
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
Cleared Oct 25, 1984
SERATEST DNA DETERMINATION
K842563
Seragen Diagnostics, Inc.
Immunology · 115d
Cleared Jul 11, 1984
LEAP LE TEST KIT
K842484
Cooper Biomedical, Inc.
Immunology · 16d
Cleared Jun 08, 1983
ANA-CHECK
K831463
Diagnostic Technology, Inc.
Immunology · 33d