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
97–120 of 182
Cleared May 11, 1994
SYN ENA SCREEN (PIN PLATE)
K940229
Elias U.S.A., Inc.
Immunology · 113d
Cleared May 11, 1994
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622
Elias U.S.A., Inc.
Immunology · 113d
Cleared May 05, 1994
JO-1 EIA TEST KIT
K935417
David A. Fuccillo, Ph.D.
Immunology · 177d
Cleared May 05, 1994
SCL-70 EIA TEST KIT
K935418
David A. Fuccillo, Ph.D.
Immunology · 177d
Cleared May 05, 1994
LA EIA TEST KIT
K935419
David A. Fuccillo, Ph.D.
Immunology · 177d
Cleared Apr 20, 1994
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K935828
Hemagen Diagnostics, Inc.
Immunology · 134d
Cleared Jan 31, 1994
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
K935129
Immuno Concepts, Inc.
Immunology · 95d
Cleared Dec 21, 1993
QUANTA LITE(TM) HISTONE ELISA
K934053
Inova Diagnostics, Inc.
Immunology · 124d
Cleared Oct 15, 1993
DIASTAT ANTI-CENTROMERE KIT
K932877
Shield Diagnostics, Ltd.
Immunology · 123d
Cleared Sep 24, 1993
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
K932850
Helix Diagnostics, Inc.
Immunology · 106d
Cleared Sep 08, 1993
ENCORE ENA COMBINED EIA
K931543
Clark Laboratories, Inc.
Immunology · 163d
Cleared Aug 05, 1993
ANTI-SS-B/LA ANTIBODY TEST
K932419
Helix Diagnostics, Inc.
Immunology · 79d
Cleared Jul 16, 1993
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
K931495
Helix Diagnostics, Inc.
Immunology · 113d
Cleared May 19, 1993
ELISA-DPXA SSA KIT
K924945
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SSB
K924946
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SM
K924947
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SM/RNP
K924948
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SCL-70
K924949
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA JO-1
K924950
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA COMBI-4
K924951
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA COMBI-6
K924952
Advanced Biological Products, Inc.
Immunology · 231d
Cleared Apr 06, 1993
SYNELISA JO-1 ANTIBODIES
K930281
Elias U.S.A., Inc.
Immunology · 75d
Cleared Apr 06, 1993
SYNELISA SCL-70 ANTIBODIES
K930417
Elias U.S.A., Inc.
Immunology · 70d
Cleared Mar 26, 1993
RHEUMELISA II JO-1 ANTIBODY TEST KIT
K930757
Biowhittaker Molecular Applications, Inc.
Immunology · 42d