FDA-Device2014-07-30Class II
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
ITC-Nexus Dx
Hazard
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Sold states
Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
Affected count
US- 315 cuvettes; OUS - 2835 cuvettes
Manufactured in
23 Nevsky St, Edison, NJ, United States
Products
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2088-2014Don't want to check this manually?
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