XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE

System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

CEPHEID

The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Mrsa/sa Blood Culture Assay; Genexpert Dx Systems (gx-i, Gx-ii, Gx-iv, Gx-xvi); Genexpert Infinity-48 System; Gene.

Pre-market Notification Details

• Device ID: K130894
• 510k Number: K130894
• Device Name: XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE
• Classification: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
• Applicant: CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189
• Contact: Rainer Ziermann Ph.d.
• Correspondent: Rainer Ziermann Ph.d.; CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189
• Product Code: NQX
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-04-01
• Decision Date: 2013-06-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07332940000141	K130894	000