DHN · Class II · 21 CFR 866.5100

FDA Product Code DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Leading manufacturers include Bio-Rad, Immuno Concepts, Inc. and Zeus Scientific, Inc..

110
Total
110
Cleared
67d
Avg days
1976
Since
110 devices
49–72 of 110
Cleared Oct 18, 1977
IFA ANTI-NDNA
K771376
Electro-Nucleonics Laboratories, Inc.
Immunology · 85d
Cleared Jun 24, 1977
ANA TEST
K771064
Gull Laboratories, Inc.
Immunology · 11d
Cleared Jul 26, 1976
ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP
K760209
Zeus Scientific, Inc.
Immunology · 17d
Cleared Jul 20, 1976
TEST, (IVDP) ANTINUCLEAR ANTIBODY
K760153
Zeus Scientific, Inc.
Immunology · 18d