Immuno Concepts Inc

Sub Assembly Lot Numbers: 0823200, 0823201, and 0825500 and Kit Lot Numbers: 826305, 0827311, 0828107, 0828108, 0828109, 0830914, 0831607, 0831606, 0829719, 0827315, 0827301, 0829413, 0829512, 0826905, 0828114, 0828804, 0829414, 0829721, 0830300, 0828307 and 0829513.

Immunology and Microbiology Devices

2

No

Worldwide Distribution, USA (NC, WI, MS, MD, IL, GA, CA, MI and Puerto Rico) and countries of Sweden, Mexico, Spain and Denmark.

ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. || The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

Kit Catalog Number 7096-09, Lot Number 0821407 and Kit Catalog Number 7696-09, Lot Number 0821404.

Immunology and Microbiology Devices

2

No

Worldwide Distribution including USA, Australia, England, Sweden and Austria.

RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.