GeneXpert® GX-II R2
GUDID 07332940007683
XPERT, GENEXPERT DX SYSTEM
CEPHEID
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory| Primary Device ID | 07332940007683 |
| NIH Device Record Key | abbeb867-b22d-4b25-b87a-b0cd09d6bff0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GeneXpert® |
| Version Model Number | GX-II R2 |
| Catalog Number | GX-II R2 |
| Company DUNS | 956711444 |
| Company Name | CEPHEID |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332940007683 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060540
FDA Product Code
| OOI | Real Time Nucleic Acid Amplification System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-11 |
| Device Publish Date | 2022-05-03 |
On-Brand Devices [GeneXpert®]
| 07332940007720 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infi |
| 07332940007713 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infi |
| 07332940007706 | XPERT, GENEXPERT DX SYSTEM |
| 07332940007690 | XPERT, GENEXPERT DX SYSTEM |
| 07332940007683 | XPERT, GENEXPERT DX SYSTEM |
| 07332940007195 | Xpress System |
| 07332940008604 | Xpert Xpress CoV-2/Flu/RSV plus |
| 07332940008581 | Xpert® Xpress CoV-2 plus |
| 07332940008161 | Xpert® Xpress GBS |
Trademark Results [GeneXpert]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENEXPERT 77328654 4026395 Live/Registered |
Cepheid 2007-11-13 |
 GENEXPERT 75771218 2534624 Live/Registered |
Cepheid 1999-08-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.