STA-QUALITY HBPM/LMWH KIT

• K Number: K010324
• Device Name: STA-QUALITY HBPM/LMWH KIT
• Manufacturer: DIAGNOSTICA STAGO, INC.
• Date Cleared: 2001-04-09 ( 66 days)
• Product Code: GGN
• Regulation Number: 864.5425
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.