GeneXpert Dx System

Basic Information

• Brand Name: GeneXpert Dx System
• Primary DI: 07332940001377
• Version / Model: GXII-2
• Catalog Number: 900-0485
• Company Name: CEPHEID
• Labeler DUNS: 956711444
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 7
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 7274db95-6e22-4975-8429-4866ff9cb9d2
• Distribution End Date: 2022-05-03

Device Description

Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXII-CLIA-L

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48031	Thermal cycler nucleic acid amplification analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332940001377	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060540	000
K173263	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 45 Degrees Celsius