GeneXpert®

Basic Information

• Brand Name: GeneXpert®
• Primary DI: 07332940008161
• Version / Model: XPRSGBS-10
• Catalog Number: XPRSGBS-10
• Company Name: CEPHEID
• Labeler DUNS: 956711444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-16
• Public Version: 1
• Public Version Date: 2024-02-26
• Public Version Status: New
• Public Device Record Key: 95724a0a-2ae9-4f19-ac18-eeb1ded233ee

Device Description

Xpert® Xpress GBS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51753	Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Group B beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332940008161	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]