Antinuclear Antibody, Antigen, Control

FDA product code LKJ · 50 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5100
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1983-06-08 – 2022-07-27

LKJ 2022-07-27

EliA Ro52, EliA Ro60

Applicant Phadia AB

K number K210902

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LKJ 2012-07-09

ANA-SCREEN WITH MDSS

Applicant Bio-Rad Laboratories

K number K113610

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LKJ 2009-04-10

ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY

Applicant Phadia US, Inc.

K number K082759

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LKJ 2008-05-02

AESKULISA ANA HEP-2, REF 30-7115US

Applicant Aesku Diagnostics

K number K081104

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LKJ 2004-12-20

BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200

Applicant Bio-Rad Laboratories, Inc.

K number K041658

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LKJ 2004-10-08

ATHENA MULTI-LYTE ANA-II TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K042416

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LKJ 2004-01-08

REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001

Applicant Corgenix, Inc.

K number K034013

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LKJ 2003-05-12

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM

Applicant Immuno Concepts, N.A. , Ltd.

K number K030775

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LKJ 2003-01-17

LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113

Applicant Bio-Rad

K number K024232

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LKJ 2003-01-17

LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114

Applicant Bio-Rad

K number K024218

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LKJ 2003-01-13

LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116

Applicant Bio-Rad

K number K024223

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LKJ 2003-01-10

LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116

Applicant Bio-Rad

K number K024226

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LKJ 2002-06-03

ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)

Applicant Diagnostic Products Corp.

K number K021257

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LKJ 2002-04-24

MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K021103

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LKJ 2001-12-10

ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K011244

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LKJ 1999-10-25

DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM

Applicant Diamedix Corp.

K number K993294

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LKJ 1998-12-22

LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210

Applicant Bio-Rad

K number K984478

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LKJ 1998-12-22

LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212

Applicant Bio-Rad

K number K984475

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LKJ 1998-12-22

LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205

Applicant Bio-Rad

K number K984473

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LKJ 1998-12-22

LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209

Applicant Bio-Rad

K number K984470

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LKJ 1998-12-22

LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211

Applicant Bio-Rad

K number K984464

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LKJ 1996-09-27

QUALITROL ANA CONTROL SERUM SET

Applicant Consolidated Technologies, Inc.

K number K961815

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LKJ 1995-12-26

HYTEC AUTOIMMUNE KITS (SS-B)

Applicant Hycor Biomedical, Inc.

K number K954891

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LKJ 1995-12-26

HYTEC AUTOIMMUNE KIT (SS-A)

Applicant Hycor Biomedical, Inc.

K number K954392

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LKJ 1995-12-15

ENZYME IMMUNOASSAY ANA SCREENING TEST KIT

Applicant Helix Diagnostics, Inc.

K number K954723

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LKJ 1995-12-15

ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT

Applicant Helix Diagnostics, Inc.

K number K954700

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LKJ 1993-11-15

DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

Applicant Shield Diagnostics, Ltd.

K number K932876

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LKJ 1993-09-24

SYNELISA CENP-B ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K931255

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LKJ 1993-08-23

RHEUMELISA II HISTONE ANTIBODY TEST KIT

Applicant Biowhittaker Molecular Applications, Inc.

K number K932679

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LKJ 1993-08-23

SYLNELISA HISTONE ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K932302

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LKJ 1992-12-01

SYN ELISA DSDNA ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K921132

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LKJ 1992-05-22

THE THERATEST EL-ANA PROFILES

Applicant Theratest Laboratories, Inc.

K number K914454

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LKJ 1992-05-01

AUTOSTAT(TM) ANTI-DSNA

Applicant Cogent Diagnotics , Ltd.

K number K913342

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LKJ 1992-03-18

ENCORE SCL-70

Applicant Clark Laboratories, Inc.

K number K920150

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LKJ 1992-02-11

ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM

Applicant Diagnostic Resources, Inc.

K number K914550

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LKJ 1991-07-30

DISTAT ANTI-SCL-70 KIT

Applicant Shield Diagnostics, Ltd.

K number K912291

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LKJ 1989-08-02

SERATEST ENA [SCL-70] KIT

Applicant Hemagen Diagnostics, Inc.

K number K894411

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LKJ 1989-07-14

QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA

Applicant Biostar Medical Products, Inc.

K number K893896

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LKJ 1989-06-23

SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM

Applicant Biostar Medical Products, Inc.

K number K893897

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LKJ 1989-04-14

ANA-5 AUTOANTIBODY PROFILE KIT

Applicant Autoimmunity Diagnostics Corp.

K number K885224

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LKJ 1988-10-27

ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)

Applicant Immco Diagnostics, Inc.

K number K883949

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LKJ 1988-10-27

ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)

Applicant Immco Diagnostics, Inc.

K number K883883

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LKJ 1988-09-22

ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY

Applicant Lipogen, Inc.

K number K882740

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LKJ 1987-11-04

NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)

Applicant Sigma Diagnostics, Inc.

K number K874115

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LKJ 1987-09-22

ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS

Applicant Cytotech, Inc.

K number K873249

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LKJ 1987-03-12

ANA TEST KIT

Applicant Val Tech Diagnostics, Inc.

K number K864668

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LKJ 1986-08-06

KALLESTAD SM/RNP TEST REAGENT

Applicant Kallestad Laboratories, Inc.

K number K862313

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LKJ 1984-10-25

SERATEST DNA DETERMINATION

Applicant Seragen Diagnostics, Inc.

K number K842563

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LKJ 1984-07-11

LEAP LE TEST KIT

Applicant Cooper Biomedical, Inc.

K number K842484

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LKJ 1983-06-08

ANA-CHECK

Applicant Diagnostic Technology, Inc.

K number K831463

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