International Medical Devices Database

Manufacturer Address
ITC-Nexus Dx, 23 Nevsky St, Edison NJ 08820-2425
Manufacturer Parent Company (2017)
Samsung Electronics Co., Ltd.
Source
USFDA
3 Events

3 devices in the database

Device Recall Hemocrhon Jr APTT Cuvettes

Model / Serial
Lot Number A4JCA001
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
Product Description
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

Device Recall International Technidyne Corporation

Model / Serial
E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
Product Description
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.

Device Recall Surgicutt Bleeding Time Device

Model / Serial
Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including Arizona andTexas. .
Product Description
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.

One manufacturer with a similar name

Learn more about the data here

ITC-Nexus Dx, Inc.

Manufacturer Address
ITC-Nexus Dx, Inc., 6-8 Olsen Ave, Edison NJ 08820-2419
Manufacturer Parent Company (2017)
Samsung Electronics Co., Ltd.
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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