STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS

• K Number: K961938
• Device Name: STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
• Manufacturer: NOVA BIOMEDICAL CORP.
• Date Cleared: 1996-06-28 ( 39 days)
• Product Code: GJS CEM CGA JPK KHP
• Regulation Number: 864.7750

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).

Summary

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