XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

CEPHEID

The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Gbs Lb Genexpert Dx Systems (gx-i, Gx-iv) Genexpert Dx Systems (gx-xvi) Genexpert Infinity-48 System (900-xxxx).

Pre-market Notification Details

• Device ID: K121539
• 510k Number: K121539
• Device Name: XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
• Classification: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
• Applicant: CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189
• Contact: Kerry J Flom
• Correspondent: Kerry J Flom; CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189
• Product Code: NJR
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-05-24
• Decision Date: 2012-11-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07332940000882	K121539	000
07332940000806	K121539	000