| Primary Device ID | 07332940009700 |
| NIH Device Record Key | da07ff57-e8b9-4ec0-903e-595e42f03ca1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GeneXpert® Xpress |
| Version Model Number | GX-IV Xpress |
| Company DUNS | 956711444 |
| Company Name | CEPHEID |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332940009700 [Primary] |
| OOI | Real Time Nucleic Acid Amplification System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-27 |
| Device Publish Date | 2026-01-19 |
| 07332940009243 | GENEXPERT Xpress System |
| 07332940009700 | GENEXPERT Xpress System Refurbished |
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 |