| Primary Device ID | 07332940000974 |
| NIH Device Record Key | 57c9e56e-aedf-469a-9f1a-b59256bfd3b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xpert Norovirus |
| Version Model Number | GXNOV-10 |
| Catalog Number | GXNOV-10 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com | |
| Phone | 1 888 838 3222 |
| techsupport@cepheid.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332940000974 [Primary] |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-29 |
| 07332940009366 - GeneXpert® | 2024-07-30 Xpert® HCV |
| 07332940008161 - GeneXpert® | 2024-02-26 Xpert® Xpress GBS |
| 07332940008581 - GeneXpert® | 2024-01-30 Xpert® Xpress CoV-2 plus |
| 07332940009243 - GeneXpert® Xpress | 2023-10-30 GENEXPERT Xpress System |
| 07332940008604 - GeneXpert® | 2023-10-03 Xpert Xpress CoV-2/Flu/RSV plus |
| 07332940007652 - Xpert® | 2022-08-08 GBS LB XC |
| 07332940007669 - Xpert® | 2022-08-08 GBS LB XC |
| 07332940007195 - GeneXpert® | 2022-05-20 Xpress System |