Panels › Microbiology › Product code LLM · Class 1

Test, Antigen, Nuclear, Epstein-Barr Virus

Regulation 866.3235

0510(k)s in 12 months (27 all time)

0recalls in 12 months (1 all time)

1recalls that name a 510(k)

Top companies in LLM

Company	510(k)s	Recalls
Zeus Scientific, Inc.	3	0
Clinical Sciences, Inc.	2	0
DiaSorin, Inc.	1	1
Granbio, Inc.	2	0
Gull Laboratories, Inc.	2	0
Immuno Concepts, Inc.	2	0
Ortho Diagnostic Systems, Inc.	2	0
Biokit, S.A.	1	0
Bion Ent., Ltd.	1	0
Clark Laboratories, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Apr 24, 2007	Diasorin Inc. DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Terminated	LLM	K946158

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