The Binding Site Group, Ltd.

864000290243  864000290832 864000290244  864000290833 864000290330  864000290834 864000290447  864000290836 864000290448  864000290837 864000290449  864000290838 864000290452  864000290844 864000290826  864000290845 864000290827  864000290846 864000290828  864000290847 864000290831  864000290850

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US Nationwide in the states of: CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, GA, MI, and the countries of Canada, China, Australia, Israel, Ireland, UK, Germany, Belgium, Italy, France, Czech republic, Spain, Portugal.

Optilite Analyser, Product Code: IE700 || Product Usage: || The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.

Lot #405566, 405567

Immunology and Microbiology Devices

2

No

U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.

Optilite Freelite Lambda Free Kit || Product Code: LK018.OPT, LK018.OPT.A || Protein testing kit.

Lot #323278, 327963

Immunology and Microbiology Devices

2

No

U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.

Human Lambda Free SPAPlus Kit || Product Code: LK018.S || Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

Lot #401413

Immunology and Microbiology Devices

2

No

U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.

Optilite IgG4 Kit || Product Code: LK009.OPT.A

Lot #400900, Exp. 12/31/2017, UDI #05051700016421

Immunology and Microbiology Devices

2

No

Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.

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 in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.