| Primary Device ID | 00845275004526 |
| NIH Device Record Key | 40d27ea0-1c4c-409c-b062-cb3b18da33f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thermo Scientific Infinity™ for Beckman Coulter AU® Chemistry Analyzers |
| Version Model Number | 106517 |
| Company DUNS | 183998769 |
| Company Name | Fisher Diagnostics |
| Device Count | 3 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 800-528-0494 |
| xx@xx.xx |
| 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 | 00845275004526 [Primary] |
| GS1 | 00845275005912 [Unit of Use] |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium |
| 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 | 2016-09-16 |
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| 00845275004076 - Thermo Scientific Trutol™ | 2019-11-19 |
| 00845275004090 - Thermo Scientific Trutol™ | 2019-11-19 |
| 00845275004106 - Thermo Scientific Trutol™ | 2019-11-19 |
| 00845275004113 - Thermo Scientific Trutol™ | 2019-11-19 |
| 00845275004823 - Thermo Scientific Trutol™ | 2019-11-19 |
| 00845275006544 - Thermo Scientific GlucoCrush™ | 2019-11-19 |