LJM · Class II · 21 CFR 866.5100

FDA Product Code LJM: Antinuclear Antibody (enzyme-labeled), Antigen, Controls

Leading manufacturers include Elias U.S.A., Inc., American Laboratory Products Co., Ltd. and Zeus Scientific, Inc..

112
Total
112
Cleared
99d
Avg days
1982
Since
112 devices
49–72 of 112
Cleared Apr 17, 1995
VARELISA HISTONE ANTIBODIES
K951207
Elias U.S.A., Inc.
Immunology · 31d
Cleared Jan 20, 1995
ANTI-HISTONE ANIBODY TEST
K943585
Immco Diagnostics, Inc.
Immunology · 182d
Cleared Dec 22, 1994
VARELISA RNP-SM ANTIBODIES
K944167
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA LA (SS-B) ANTIBODIES
K944168
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA RO (SS-A) ANTIBODIES
K944169
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SM ANTIBODIES
K944170
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA CENTROMERE ANTIBODIES
K944171
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SCL-70 ANTIBODIES
K944172
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA JO-1 ANTIBODIES
K944173
Elias U.S.A., Inc.
Immunology · 118d
Cleared Jun 30, 1994
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
K941509
Bio-Rad
Immunology · 93d
Cleared Jun 10, 1994
ENA SCREEN ELISA TEST SYSTEM
K941014
Zeus Scientific, Inc.
Immunology · 99d
Cleared Jun 10, 1994
ENA PROFILE-6 ELISA TEST SYSTEM
K941409
Zeus Scientific, Inc.
Immunology · 79d
Cleared Mar 25, 1994
SYNELISA ANA TOTAL
K935468
Elias U.S.A., Inc.
Immunology · 133d
Cleared Mar 25, 1994
ELIAS ANA TOTAL
K940641
Elias U.S.A., Inc.
Immunology · 39d
Cleared Dec 15, 1993
AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM
K933267
Zeus Scientific, Inc.
Immunology · 162d
Cleared Dec 03, 1993
SYNELISA ANA PROFILE
K932206
Elias U.S.A., Inc.
Immunology · 211d
Cleared Jun 11, 1993
SYNELISA RO ABS / LA ABS
K930209
Elias U.S.A., Inc.
Immunology · 147d
Cleared Nov 02, 1992
KALESTAD ANA MICROPLATE EIA
K924087
Bio-Rad Laboratories, Inc.
Immunology · 81d
Cleared Nov 02, 1992
ACCUTEX SLE LATEX TEST
K924248
J.S. Medical Assoc.
Immunology · 70d
Cleared Jul 14, 1992
DIASTAT ANTI-HISTONE KIT
K920616
Shield Diagnostics, Ltd.
Immunology · 154d
Cleared Mar 17, 1992
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
K915272
Hemagen Diagnostics, Inc.
Immunology · 113d
Cleared Jan 25, 1991
UBI MAGIWEL(TM) ANA QUANTITATIVE
K910033
United Biotech, Inc.
Immunology · 21d
Cleared Dec 07, 1990
DIASTAT ENA PROFILE
K905190
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Sep 06, 1990
ANTI-SCI-70 MICROASSAY
K902915
Diamedix Corp.
Immunology · 65d