Extractable Antinuclear Antibody, Antigen And Control

LLL 2026-06-25

EliA CTD 13 Screen

Applicant Phadia AB

K number K253367

LLL 2025-10-22

Alegria Flash CTD Screen

Applicant Zeus Scientific

K number K250666

LLL 2025-09-19

Alegria Flash ENA Screen

Applicant Zeus Scientific

K number K250408

LLL 2023-09-29

Aptiva CTD Essential Reagent

Applicant Inova Diagnostics, Inc.

K number K213403

LLL 2019-11-29

EliA SymphonyS Immunoassay

Applicant Phadia AB

K number K190710

LLL 2018-06-25

QUANTA Flash HMGCR Reagents

Applicant Inova Diagnostics, Inc.

K number K180975

LLL 2016-06-01

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls

Applicant Inova Diagnostics, Inc.

K number K152635

LLL 2016-02-12

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

Applicant Inova Diagnostics, Inc.

K number K151429

LLL 2013-05-07

QUANTA FLASH ENA7

Applicant Inova Diagnostics, Inc.

K number K122923

LLL 2013-04-09

EUROIMMUN ANTI-ENA POOL ELISA (IGG)

Applicant Euroimmun US

K number K112996

LLL 2011-12-02

IMMULISA SCI-70 ANTIBODY ELISA

Applicant Immco Diagnostics, Inc.

K number K113143

LLL 2010-12-03

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS

Applicant Biomedical Diagnostics (Bmd) SA

K number K102607

LLL 2008-01-15

ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01

Applicant Phadia US, Inc.

K number K072149

LLL 2006-03-13

FIDIS CONNECTIVE 10, MODEL MX006

Applicant Biomedical Diagnostics (Bmd) SA

K number K053653

LLL 2005-10-03

FIDIS CONNECTIVE 8

Applicant Biomedical Diagnostics (Bmd) SA

K number K050286

LLL 2005-05-31

ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400

Applicant Bioarray Solutions, Ltd.

K number K043067

LLL 2004-07-14

AESKULISA ENA 6 S

Applicant Aesku Diagnostics

K number K041753

LLL 2004-03-08

QUANTA PLEX SLE PROFILE 8

Applicant Inova Diagnostics, Inc.

K number K040160

LLL 2003-12-22

MESACUP-2 TEST JO-1, MODEL 10756

Applicant Rhigene, Inc.

K number K033528

LLL 2003-12-16

AESKULISA ANA 8PRO

Applicant Aesku, Inc.

K number K032469

LLL 2003-06-25

QUANTA PLEX ENA PROFILE 6

Applicant Inova Diagnostics, Inc.

K number K031450

LLL 2003-04-24

QUANTA PLEX ENA PROFILE 5

Applicant Inova Diagnostics, Inc.

K number K030681

LLL 2001-07-27

QUANTA PLEX ENA PROFILE 4

Applicant Inova Diagnostics, Inc.

K number K011140

LLL 2001-03-01

ENA EIA KIT

Applicant The Binding Site, Ltd.

K number K010147

LLL 2001-03-01

ENA EIA KIT RANGE

Applicant The Binding Site, Ltd.

K number K010146

LLL 2001-02-23

ENA SCREEN EIA KIT

Applicant The Binding Site, Ltd.

K number K010148

LLL 2000-10-13

AUTOSTAT II ENA-4 PROFILE ELISA

K number K003057

LLL 2000-10-13

AUTOSTAT II ENA-6 PROFILE ELISA

K number K003054

LLL 2000-05-09

RHIGENE MESACUP2 TEST- SSB

Applicant Rhigene, Inc.

K number K000751

LLL 2000-05-09

RHIGENE MESACUP2 TEST- SCL-70

Applicant Rhigene, Inc.

K number K000750

LLL 2000-05-09

RHIGENE MESACUP2 TEST- SSA

Applicant Rhigene, Inc.

K number K000749

LLL 2000-04-05

ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST

Applicant Helix Diagnostics, Inc.

K number K000489

LLL 2000-01-12

ENA PROFILE ELISA TEST SYSTEM

Applicant Trinity Biotech USA

K number K993839

LLL 2000-01-11

MDI SM TEST

Applicant Micro Detect, Inc.

K number K994029

LLL 2000-01-11

MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM

Applicant Micro Detect, Inc.

K number K993971

LLL 1999-06-17

QUANTA LITE ANA ELISA

Applicant Inova Diagnostics, Inc.

K number K991657

LLL 1999-04-28

AUTOSTAT II ANTI-JO-1 ELISA

K number K990798

LLL 1999-04-28

AUTOSTAT II ANTI-SCL-70 ELISA

K number K990797

LLL 1999-04-28

AUTOSTAT II ANTI-SS-A/RO ELISA

K number K990627

LLL 1999-04-28

AUTOSTAT II ANTI-SS-B/LA ELISA

K number K990626

LLL 1998-12-28

AUTOSTAT II ENA SCREEN ELISA

K number K983921

LLL 1998-12-22

LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206

Applicant Bio-Rad

K number K984462

LLL 1998-11-18

THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

Applicant Zeus Scientific, Inc.

K number K983464

LLL 1998-11-18

THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC

Applicant Zeus Scientific, Inc.

K number K983426

LLL 1998-11-18

THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET

Applicant Zeus Scientific, Inc.

K number K983425

LLL 1998-11-18

THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

Applicant Zeus Scientific, Inc.

K number K983423

LLL 1998-11-18

THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S

Applicant Zeus Scientific, Inc.

K number K983376

LLL 1998-10-07

QUANTA LITE CHROMATIN ELISA

Applicant Inova Diagnostics, Inc.

K number K982603

LLL 1998-08-13

EL-ANA PROFILES: EL-ENA/5

Applicant Theratest Laboratories, Inc.

K number K982622

LLL 1998-08-13

EL-ANA PROFILES: EL-ENA/4

Applicant Theratest Laboratories, Inc.

K number K982150

LLL 1998-07-29

QUANTA LITE TPO ELISA

Applicant Inova Diagnostics, Inc.

K number K981857

LLL 1998-06-15

SERAQUEST ANTI-SSB

Applicant Quest Intl., Inc.

K number K980639

LLL 1998-04-23

DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM

Applicant Diamedix Corp.

K number K980759

LLL 1997-04-08

IS-ANTI-SCL-70 TEST SYSTEM (720-280)

Applicant Diamedix Corp.

K number K970239

LLL 1997-04-08

IS-ANTI-SM/RNP (720-270)

Applicant Diamedix Corp.

K number K970238

LLL 1997-04-08

IS-ANTI-SSB TEST SYSTEM (720-260)

Applicant Diamedix Corp.

K number K970237

LLL 1997-04-08

IS-ANTI-JO-1 TEST SYSTEM

Applicant Diamedix Corp.

K number K970228

LLL 1997-04-08

IS-ANTI-SM TEST SYSTEM

Applicant Diamedix Corp.

K number K970220

LLL 1997-04-08

IS-ANTI-SSA TEST SYSTEM

Applicant Diamedix Corp.

K number K970218

LLL 1997-04-08

MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM

Applicant Mardx Diagnostics, Inc.

K number K964787

LLL 1997-03-07

HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY

Applicant Hycor Biomedical, Inc.

K number K962731

LLL 1997-03-07

HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY

Applicant Hycor Biomedical, Inc.

K number K962728

LLL 1997-03-07

HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY

Applicant Hycor Biomedical, Inc.

K number K962727

LLL 1997-03-07

HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY

Applicant Hycor Biomedical, Inc.

K number K962722

LLL 1997-03-07

HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY

Applicant Hycor Biomedical, Inc.

K number K962720

LLL 1997-03-07

HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY

Applicant Hycor Biomedical, Inc.

K number K962719

LLL 1997-03-07

HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY

Applicant Hycor Biomedical, Inc.

K number K962578

LLL 1996-09-13

RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K963275

LLL 1996-07-10

QUANTA LITE ENA 6 ELISA

Applicant Inova Diagnostics, Inc.

K number K961913

LLL 1996-04-19

RELISA JO-1 ANTIBODY TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K955605

LLL 1996-04-19

RELISA SM/RNP ANTIBODY TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K955604

LLL 1996-04-19

RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K955603

LLL 1996-04-19

RELSIA SCL-70 ANTIBODY TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K955602

LLL 1996-03-20

ORGENTEC ENASCREEN ELISA ASSAY

Applicant Orgentec

K number K955134

LLL 1996-03-20

ORGENTEC ENASCREEN PIN IMMUNO ASSAY

Applicant Orgentec

K number K955133

LLL 1996-03-20

HYTEC AUTOIMMUNE KIT (JO-1)

Applicant Hycor Biomedical, Inc.

K number K954895

LLL 1996-03-20

HYTEC AUTOIMMUNE KITS (SCL-70)

Applicant Hycor Biomedical, Inc.

K number K954894

LLL 1995-12-26

HYTEC AUTOMMUNE KIT (ENA)

Applicant Hycor Biomedical, Inc.

K number K954890

LLL 1995-08-24

ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT

Applicant Helix Diagnostics, Inc.

K number K952253

LLL 1995-06-05

HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)

K number K952077

LLL 1995-06-05

HEMAGEN ENA SCREENING KIT (EIA METHOD)

K number K952076

LLL 1995-03-29

HEMAGEN ENA SM/RMP KIT (EIA METHOD)

K number K950414

LLL 1995-02-22

HEMAGEN ENA JO-1 KIT (EIA METHOD)

K number K946124

LLL 1995-02-22

HEMAGEN ENA SM KIT (EIA METHOD)

K number K946123

LLL 1995-02-22

HEMAGEN ENA SCL-70 KIT (EIA METHOD)

K number K946122

LLL 1995-02-22

HEMAGEN ENA SS-A KIT (EIA METHOD)

K number K946121

LLL 1995-02-22

HEMAGEN ENA SS-B KIT (EIA METHOD)

K number K946120

LLL 1994-12-02

ANTI DS-DNA

Applicant Sigma Diagnostics, Inc.

K number K943291

LLL 1994-11-21

DIASTAT ENA SINGLE WELL SCREEN KIT

Applicant Shield Diagnostics, Ltd.

K number K944505

LLL 1994-10-25

QUANTA LITE ENA 5 ELISA KIT

Applicant Inova Diagnostics, Inc.

K number K943076

LLL 1994-07-28

ANA SCREEN ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K940362

LLL 1994-06-02

ENA EIA TEST KIT

K number K935413

LLL 1994-05-11

ELIAS ENA SCREEN (MICROTITER PLATE)

Applicant Elias U.S.A., Inc.

K number K940622

LLL 1994-05-11

SYN ENA SCREEN (PIN PLATE)

Applicant Elias U.S.A., Inc.

K number K940229

LLL 1994-05-05

LA EIA TEST KIT

K number K935419

LLL 1994-05-05

SCL-70 EIA TEST KIT

K number K935418

LLL 1994-05-05

JO-1 EIA TEST KIT

K number K935417

LLL 1994-04-20

HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)

K number K935828

LLL 1994-01-31

RELISA ENA ANTIBODY SCREENING TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K935129