STAPHAUREX PLUS(TM)

Kit, Screening, Staphylococcus Aureus

MUREX DIAGNOSTICS LIMITD

The following data is part of a premarket notification filed by Murex Diagnostics Limitd with the FDA for Staphaurex Plus(tm).

Pre-market Notification Details

• Device ID: K945538
• 510k Number: K945538
• Device Name: STAPHAUREX PLUS(TM)
• Classification: Kit, Screening, Staphylococcus Aureus
• Applicant: MUREX DIAGNOSTICS LIMITD CENTRAL ROAD, TEMPLE HILL DARTFORD, KENT DA1 5LR England, DE
• Product Code: JWX
• CFR Regulation Number: 866.2660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-14
• Decision Date: 1995-06-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05056080501529	K945538	000
05056080501512	K945538	000