| Primary Device ID | 07332940004804 |
| NIH Device Record Key | e1a93c06-8a09-4366-a4b3-f2d6b0f96d55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartCycler Dx System |
| Version Model Number | SC2500N4-1 |
| 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 |
| 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 | |
| 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 | |
| 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 -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332940004804 [Primary] |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 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 | 2016-09-12 |
| 07332940004910 | SC2500N17-1 |
| 07332940004903 | SC2500N18-1 |
| 07332940004880 | SC2500N19-1 |
| 07332940004866 | SC2500N2-1 |
| 07332940004842 | SC2500N3-1 |
| 07332940004835 | SC2500N3-1R |
| 07332940004804 | SC2500N4-1 |
| 07332940004798 | SC2500N4-1R |
| 07332940004767 | SC2500N5-1 |
| 07332940004743 | SC2500N6-1 |
| 07332940004606 | SC2500N1-1 |
| 07332940004583 | SC2500N12-1 |
| 07332940004569 | SC2500N13-1 |
| 07332940004545 | SC2500N14-1 |
| 07332940004538 | SC2500N15-1 |
| 07332940004521 | SC2500N16-1 |