Panels › Immunology › Product code DEM · Class 2

Alpha-1-Antitrypsin, Antigen, Antiserum, Control

Regulation 866.5130

0510(k)s in 12 months (30 all time)

0recalls in 12 months (1 all time)

1recalls that name a 510(k)

Top companies in DEM

Company	510(k)s	Recalls
Ventana Medical Systems, Inc.	5	0
The Binding Site, Ltd.	2	0
The Binding Site Group , Ltd.	1	1
Dade Behring, Inc.	2	0
Kallestad Diag, A Div. of Erbamont, Inc.	2	0
Applications Lab	1	0
Atlantic Antibodies	1	0
Bayer Diagnostics Corp.	1	0
Beckman Instruments, Inc.	1	0
Biokit, S.A.	1	0

Date	Firm and product	Code	Linked 510(k)
Aug 23, 2017	The Binding Site Group, Ltd. Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative Terminated	DEM	K123256

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