ITC-Nexus Dx

Lot Number A4JCA001

Hematology and Pathology Devices

2

No

Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.

Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08

Hematology and Pathology Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.

Hemochron Jr. Citrate APTT Cuvette || 510(k) K014008 || A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017

Hematology and Pathology Devices

2

No

Nationwide Distribution including Arizona andTexas. .

Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. || The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.