Instrumentation Laboratory (IL), a developer of in-vitro diagnostic instruments, has secured the US Food and Drug Administration (FDA) 510(k) clearance of its HemosIL HIT-Ab (PF4-H) assay to be used on ACL TOP Family Hemostasis Testing Systems.

HemosIL HIT-Ab is a fully automated, on-demand assay to be used for Heparin-Induced Thrombocytopenia (HIT) on a Hemostasis testing system.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The assay detects antibodies related to HIT.

"Our mission is to develop products that enhance patient care while enabling greater efficiency in the laboratory."

The ready-to-use liquid immunoassay generates results in minutes on an on-demand basis round the clock, thereby enabling clinicians to arrive at timely and well-informed therapeutic decisions required during critical cases.

The ACL TOP family of testing systems are a hemostasis testing platform which are used for routine or specialty testing in mid to high-volume labs thereby resulting in efficient patient care.

IL worldwide hemostasis marketing director Remo Tazzi said: "Our mission is to develop products that enhance patient care while enabling greater efficiency in the laboratory.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“The HemosIL HIT-Ab(PF4-H) assay is an exemplary achievement of this goal."

HIT is a commonly occurring side effect of the administration of heparin therapy which if untreated can cause stroke, pulmonary embolism and death.

The addressing of HIT requires terminating heparin therapy, and involving expensive alternative anticoagulants.

Delay in diagnosis due to prolonged tests can increase the bleeding risk in patient, as well as increase the associated cost for the treatment.

It is addressed by the availability of the on-demand HemosIL HIT-Ab which facilitates quick treatment decisions while reducing patient risk and cost.