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
73–96 of 182
Cleared Mar 20, 1996
ORGENTEC ENASCREEN PIN IMMUNO ASSAY
K955133
Orgentec
Immunology · 132d
Cleared Mar 20, 1996
ORGENTEC ENASCREEN ELISA ASSAY
K955134
Orgentec
Immunology · 132d
Cleared Dec 26, 1995
HYTEC AUTOMMUNE KIT (ENA)
K954890
Hycor Biomedical, Inc.
Immunology · 62d
Cleared Jun 05, 1995
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K952076
Hemagen Diagnostics, Inc.
Immunology · 33d
Cleared Jun 05, 1995
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K952077
Hemagen Diagnostics, Inc.
Immunology · 33d
Cleared Mar 29, 1995
HEMAGEN ENA SM/RMP KIT (EIA METHOD)
K950414
Hemagen Diagnostics, Inc.
Immunology · 57d
Cleared Feb 22, 1995
HEMAGEN ENA SS-B KIT (EIA METHOD)
K946120
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SS-A KIT (EIA METHOD)
K946121
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K946122
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SM KIT (EIA METHOD)
K946123
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA JO-1 KIT (EIA METHOD)
K946124
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Dec 02, 1994
ANTI DS-DNA
K943291
Sigma Diagnostics, Inc.
Immunology · 147d
Cleared Nov 21, 1994
DIASTAT ENA SINGLE WELL SCREEN KIT
K944505
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Oct 25, 1994
QUANTA LITE ENA 5 ELISA KIT
K943076
Inova Diagnostics, Inc.
Immunology · 119d
Cleared Jul 28, 1994
ANA SCREEN ELISA TEST SYSTEM
K940362
Zeus Scientific, Inc.
Immunology · 183d
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 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 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 04, 1993
QUANTA LITE(TM) JO-1 ELISA KIT
K926562
Inova Diagnostics, Inc.
Immunology · 63d