Xpert GBS

Basic Information

• Brand Name: Xpert GBS
• Primary DI: 07332940000127
• Version / Model: GXGBS-100N-10
• Catalog Number: GXGBS-100N-10
• Company Name: CEPHEID
• Labeler DUNS: 956711444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 495a09ce-7cd6-4433-887f-9ce579c2cae3

Device Description

Xpert GBS kit; 10 test kit

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	07332940000127	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060540	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 28 Degrees Celsius