LLL · Class II · 21 CFR 866.5100

FDA Product Code LLL: Extractable Antinuclear Antibody, Antigen And Control

Leading manufacturers include Inova Diagnostics, Inc., Hemagen Diagnostics, Inc. and Diamedix Corp..

182
Total
182
Cleared
110d
Avg days
1981
Since
182 devices
145–168 of 182
Cleared Feb 04, 1985
SERATEST ENA(RNP/SM) DETERMINATION
K844743
Seragen Diagnostics, Inc.
Immunology · 61d
Cleared Dec 18, 1984
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
K843978
Behring Diagnostics, Inc.
Immunology · 68d
Cleared May 22, 1984
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
K840221
Zeus Scientific, Inc.
Microbiology · 124d
Cleared Apr 27, 1983
ENA TEST KIT SM & RNP AUTO ANTIBODY
K831036
Calbiochem-Behring Corp.
Immunology · 27d