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In-vivo Thrombogenicity Test

In-vivo Thrombogenicity Test

The In-vivo Thrombogenicity test determines a comparative thromboresistent for medical devices that are intended for blood contact. This test enables manufacturers to see if the medical devices cause any potentially undesirable effects on humans, such as activation of platelets, formation of a thrombus, embolism or injury to cells. This test complies with ISO 10993-4.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

ISO 10993

Pricing/Quote

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SCX670 - Hemocompatibility: Dog Thrombogenicity
Per test1+Quote
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SCX680 - Hemocompatibility: Pig Thrombogenicity
Per test1+Quote
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SCX690 - Hemocompatibility: Sheep Thrombogenicity
Per test1+Quote
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SCX670 - Hemocompatibility: Dog Thrombogenicity
Per test1+Quote
SCX680 - Hemocompatibility: Pig Thrombogenicity
Per test1+Quote
SCX690 - Hemocompatibility: Sheep Thrombogenicity
Per test1+Quote

Turn Around Time

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.


Sample Specifications

SCX670: Turn Around Time is 42 days from PDS approval. 2 test devices and 2 predicates.
SCX680: Turn Around Time is 42 days from PDS approval. 2 test devices and 2 predicates.
SCX690: Turn Around Time is 42 days from PDS approval. 2 test devices and 2 predicates.

Study Outline

The In-vivo Thrombogenicity test generates safety data for a blood contacting device. While in use, blood contacting medical device interactions may have potentially undesirable effects on humans. This test is designed to determine the comparative thromboresistance of a medical device intended for blood contact by implanting the test article in the venous system of a canine study model. Its performance is then compared to an appropriate negative control device.