LKJ

Product Code: LKJ


Products Classified as LKJ

3031Antinuclear Antibody, Antigen, ControlAntinuclear Antibody Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3031Antinuclear Antibody, Antigen, ControlAntinuclear Antibody Immunological Test System.

FDA Consensus Standards

Antinuclear Antibody, Antigen, Control [21709]21 CFR §866.5100 🔎

Pre-market Notifications for LKJ

K210902EliA Ro52, EliA Ro60Phadia AB
K113610ANA-SCREEN WITH MDSSBio-Rad Laboratories
K082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPHADIA US INC.
K081104AESKULISA ANA HEP-2, REF 30-7115USAESKU.DIAGNOSTICS
K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZEUS SCIENTIFIC, INC.
K041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200BIO-RAD LABORATORIES, INC.
K034013REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001CORGENIX, INC.
K030775AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUMIMMUNO CONCEPTS, N.A., LTD
K024232LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113BIO-RAD
K024218LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114BIO-RAD
K024226LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116BIO-RAD
K024223LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116BIO-RAD
K021103MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEMZEUS SCIENTIFIC, INC.
K011244ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEMZEUS SCIENTIFIC, INC.
K993294DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEMDIAMEDIX CORP.

Global Unique Device Identification Database

00817273020396Antinuclear Antibody, Antigen, Control
00850487007425Antinuclear Antibody, Antigen, Control
00850487007302Antinuclear Antibody, Antigen, Control
00847865002721ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847817022319ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847817021688ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847817007026ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847817007019ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847817006999ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847817006982ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847817006913ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847661000174ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847661000167ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847661000143ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
00847661000136ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL

Maude Adverse Events

DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROLEURO DIAGNOSTICA AB2018-02-22
DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROLEURO DIAGNOSTICA AB2018-02-22
DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROLEURO DIAGNOSTICA AB2017-05-31
DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROLEURO DIAGNOSTICA AB2017-03-06
REAGENT RED BLOOD CELLS BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-30
SERACLONE ANTI-K (KEL1)BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-23
ANTI-HUMAN GLOBULIN ANTI-IGGBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-23
ANTI-HUMAN GLOBULIN ANTI-IGGBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-23
REAGENT RED BLOOD CELLS BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-03
REAGENT RED BLOOD CELLS BIOTESTCELL P3BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-03
REAGENT RED BLOOD CELLS BIOTESTCELL IIIBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-03
REAGENT RED BLOOD CELLS BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-03
REAGENT RED BLOOD CELLS BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-07-21
REAGENT RED BLOOD CELLS BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-07-21
REAGENT RED BLOOD CELLS BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-06-17
REAGENT RED BLOOD CELLS BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-06-15
ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREENBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-04-12
REAGENT RED BLOOD CELLS BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-04-04
ANTI-HUMAN GLOBULIN (RABBIT, POLYCLONAL)BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-03-17
BLOOD GROUPING REAGENT ANTI-S (MNS3)BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-03-04
BLOOD GROUPING REAGENT ANTI-S (MNS3)BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-02-01
REAGENT RED BLOOD CELLS BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2010-12-15
BIOTESTCELL 3BIO-RAD MEDICAL DIAGNOSTICS GMBH2010-09-01
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