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Panels › Immunology › Product code LKJ · Class 2

Antinuclear Antibody, Antigen, Control

Regulation 866.5100

0510(k)s in 12 months (50 all time)

0recalls in 12 months (13 all time)

12recalls that name a 510(k)

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Top companies in LKJ

Company	510(k)s	Recalls
Bio-Rad Laboratories	2	9
Bio-Rad	9	0
Euro Diagnostica AB	0	4
Elias U.S.A., Inc.	3	0
Zeus Scientific, Inc.	3	0
Biostar Medical Products, Inc.	2	0
Helix Diagnostics, Inc.	2	0
Hycor Biomedical, Inc.	2	0
Immco Diagnostics, Inc.	2	0
Shield Diagnostics, Ltd.	2	0

Date	Firm and product	Code	Linked 510(k)
Nov 1, 2019	Bio-Rad Laboratories, Inc. BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101 Terminated	LKJ	K041658 K113610
Aug 23, 2018	Euro Diagnostica AB is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended Terminated	LKJ	K912291
Dec 20, 2017	Euro Diagnostica AB Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definit Terminated	LKJ	K932876
May 22, 2017	Euro Diagnostica AB DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human s Terminated	LKJ	K932876
Oct 15, 2015	Euro Diagnostica AB DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA Terminated	LKJ	K932876
Mar 2, 2011	Bio-Rad Laboratories Inc Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. Intended to Terminated	LKJ	K954723
Mar 2, 2011	Bio-Rad Laboratories Inc DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories. Terminated	LKJ	K954723
Dec 13, 2010	Bio-Rad Laboratories Inc Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics. Terminated	LKJ	K954723
Dec 13, 2010	Bio-Rad Laboratories Inc Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc. Terminated	LKJ	K954723
Dec 13, 2010	Bio-Rad Laboratories Inc Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used Terminated	LKJ	None listed
Dec 6, 2010	Bio-Rad Laboratories Inc Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN manufactured by Bio-Rad, Hercules, CA. Terminated	LKJ	K954723
Dec 6, 2010	Bio-Rad Laboratories Inc Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA Terminated	LKJ	K954723
Jun 11, 2008	Bio-Rad Laboratories BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is us Terminated	LKJ	K043341

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