Atlas FDA

LLL

181 FDA 510(k) clearances · Product code

75 daysmedian time to decision
231 days90th percentile
181clearances measured

FDA profile

Official device name
Extractable Antinuclear Antibody, Antigen And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
EliA CTD 13 Screen (K253367)Phadia AB2026-06-25
Alegria Flash CTD Screen (K250666)Zeus Scientific2025-10-22
Alegria Flash ENA Screen (K250408)Zeus Scientific2025-09-19
Aptiva CTD Essential Reagent (K213403)Inova Diagnostics, Inc.2023-09-29
EliA SymphonyS Immunoassay (K190710)Phadia AB2019-11-29
QUANTA Flash HMGCR Reagents (K180975)Inova Diagnostics, Inc.2018-06-25
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls (K152635)Inova Diagnostics, Inc.2016-06-01
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols (K151429)Inova Diagnostics, Inc.2016-02-12
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA (K142781)Immco Diagnostics, Inc.2015-03-31
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS (K141328)Inova Diagnostics, Inc.2015-02-12
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS (K141210)Inova Diagnostics, Inc.2015-01-29
QUANTA FLASH ENA7 (K122923)Inova Diagnostics, Inc.2013-05-07
EUROIMMUN ANTI-ENA POOL ELISA (IGG) (K112996)Euroimmun US2013-04-09
IMMULISA SCI-70 ANTIBODY ELISA (K113143)Immco Diagnostics, Inc.2011-12-02
FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS (K102607)Biomedical Diagnostics (Bmd) SA2010-12-03
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 (K072149)Phadia US, Inc.2008-01-15
FIDIS CONNECTIVE 10, MODEL MX006 (K053653)Biomedical Diagnostics (Bmd) SA2006-03-13
FIDIS CONNECTIVE 8 (K050286)Biomedical Diagnostics (Bmd) SA2005-10-03
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 (K043067)Bioarray Solutions, Ltd.2005-05-31
AESKULISA ENA 6 S (K041753)Aesku Diagnostics2004-07-14
QUANTA PLEX SLE PROFILE 8 (K040160)Inova Diagnostics, Inc.2004-03-08
MESACUP-2 TEST JO-1, MODEL 10756 (K033528)Rhigene, Inc.2003-12-22
AESKULISA ANA 8PRO (K032469)Aesku, Inc.2003-12-16
QUANTA PLEX ENA PROFILE 6 (K031450)Inova Diagnostics, Inc.2003-06-25
QUANTA PLEX ENA PROFILE 5 (K030681)Inova Diagnostics, Inc.2003-04-24
QUANTA PLEX ENA PROFILE 4 (K011140)Inova Diagnostics, Inc.2001-07-27
ENA EIA KIT RANGE (K010146)The Binding Site, Ltd.2001-03-01
ENA EIA KIT (K010147)The Binding Site, Ltd.2001-03-01
ENA SCREEN EIA KIT (K010148)The Binding Site, Ltd.2001-02-23
AUTOSTAT II ENA-6 PROFILE ELISA (K003054)Cogent Diagnotics , Ltd.2000-10-13
AUTOSTAT II ENA-4 PROFILE ELISA (K003057)Cogent Diagnotics , Ltd.2000-10-13
RHIGENE MESACUP2 TEST- SSA (K000749)Rhigene, Inc.2000-05-09
RHIGENE MESACUP2 TEST- SCL-70 (K000750)Rhigene, Inc.2000-05-09
RHIGENE MESACUP2 TEST- SSB (K000751)Rhigene, Inc.2000-05-09
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST (K000489)Helix Diagnostics, Inc.2000-04-05
ENA PROFILE ELISA TEST SYSTEM (K993839)Trinity Biotech USA2000-01-12
MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM (K993971)Micro Detect, Inc.2000-01-11
MDI SM TEST (K994029)Micro Detect, Inc.2000-01-11
QUANTA LITE ANA ELISA (K991657)Inova Diagnostics, Inc.1999-06-17
AUTOSTAT II ANTI-JO-1 ELISA (K990798)Cogent Diagnotics , Ltd.1999-04-28
AUTOSTAT II ANTI-SS-B/LA ELISA (K990626)Cogent Diagnotics , Ltd.1999-04-28
AUTOSTAT II ANTI-SCL-70 ELISA (K990797)Cogent Diagnotics , Ltd.1999-04-28
AUTOSTAT II ANTI-SS-A/RO ELISA (K990627)Cogent Diagnotics , Ltd.1999-04-28
AUTOSTAT II ENA SCREEN ELISA (K983921)Cogent Diagnotics , Ltd.1998-12-28
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 (K984462)Bio-Rad1998-12-22
THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC (K983426)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S (K983376)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET (K983425)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983423)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983464)Zeus Scientific, Inc.1998-11-18
QUANTA LITE CHROMATIN ELISA (K982603)Inova Diagnostics, Inc.1998-10-07
EL-ANA PROFILES: EL-ENA/4 (K982150)Theratest Laboratories, Inc.1998-08-13
EL-ANA PROFILES: EL-ENA/5 (K982622)Theratest Laboratories, Inc.1998-08-13
QUANTA LITE TPO ELISA (K981857)Inova Diagnostics, Inc.1998-07-29
SERAQUEST ANTI-SSB (K980639)Quest Intl., Inc.1998-06-15
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM (K980759)Diamedix Corp.1998-04-23
IS-ANTI-JO-1 TEST SYSTEM (K970228)Diamedix Corp.1997-04-08
IS-ANTI-SM TEST SYSTEM (K970220)Diamedix Corp.1997-04-08
IS-ANTI-SSA TEST SYSTEM (K970218)Diamedix Corp.1997-04-08
IS-ANTI-SM/RNP (720-270) (K970238)Diamedix Corp.1997-04-08
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM (K964787)Mardx Diagnostics, Inc.1997-04-08
IS-ANTI-SSB TEST SYSTEM (720-260) (K970237)Diamedix Corp.1997-04-08
IS-ANTI-SCL-70 TEST SYSTEM (720-280) (K970239)Diamedix Corp.1997-04-08
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY (K962578)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY (K962727)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY (K962720)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY (K962731)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY (K962719)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY (K962722)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY (K962728)Hycor Biomedical, Inc.1997-03-07
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (K963275)Immuno Concepts, Inc.1996-09-13
QUANTA LITE ENA 6 ELISA (K961913)Inova Diagnostics, Inc.1996-07-10
RELISA SM/RNP ANTIBODY TEST SYSTEM (K955604)Immuno Concepts, Inc.1996-04-19
RELSIA SCL-70 ANTIBODY TEST SYSTEM (K955602)Immuno Concepts, Inc.1996-04-19
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM (K955603)Immuno Concepts, Inc.1996-04-19
RELISA JO-1 ANTIBODY TEST SYSTEM (K955605)Immuno Concepts, Inc.1996-04-19
HYTEC AUTOIMMUNE KITS (SCL-70) (K954894)Hycor Biomedical, Inc.1996-03-20
ORGENTEC ENASCREEN ELISA ASSAY (K955134)Orgentec1996-03-20
ORGENTEC ENASCREEN PIN IMMUNO ASSAY (K955133)Orgentec1996-03-20
HYTEC AUTOIMMUNE KIT (JO-1) (K954895)Hycor Biomedical, Inc.1996-03-20
HYTEC AUTOMMUNE KIT (ENA) (K954890)Hycor Biomedical, Inc.1995-12-26
ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT (K952253)Helix Diagnostics, Inc.1995-08-24
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) (K952077)Hemagen Diagnostics, Inc.1995-06-05
HEMAGEN ENA SCREENING KIT (EIA METHOD) (K952076)Hemagen Diagnostics, Inc.1995-06-05
HEMAGEN ENA SM/RMP KIT (EIA METHOD) (K950414)Hemagen Diagnostics, Inc.1995-03-29
HEMAGEN ENA SS-A KIT (EIA METHOD) (K946121)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA SS-B KIT (EIA METHOD) (K946120)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA JO-1 KIT (EIA METHOD) (K946124)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA SM KIT (EIA METHOD) (K946123)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA SCL-70 KIT (EIA METHOD) (K946122)Hemagen Diagnostics, Inc.1995-02-22
ANTI DS-DNA (K943291)Sigma Diagnostics, Inc.1994-12-02
DIASTAT ENA SINGLE WELL SCREEN KIT (K944505)Shield Diagnostics, Ltd.1994-11-21
QUANTA LITE ENA 5 ELISA KIT (K943076)Inova Diagnostics, Inc.1994-10-25
ANA SCREEN ELISA TEST SYSTEM (K940362)Zeus Scientific, Inc.1994-07-28
ENA EIA TEST KIT (K935413)David A. Fuccillo, Ph.D.1994-06-02
ELIAS ENA SCREEN (MICROTITER PLATE) (K940622)Elias U.S.A., Inc.1994-05-11
SYN ENA SCREEN (PIN PLATE) (K940229)Elias U.S.A., Inc.1994-05-11
JO-1 EIA TEST KIT (K935417)David A. Fuccillo, Ph.D.1994-05-05
LA EIA TEST KIT (K935419)David A. Fuccillo, Ph.D.1994-05-05
SCL-70 EIA TEST KIT (K935418)David A. Fuccillo, Ph.D.1994-05-05
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