| Primary Device ID | 08056040148945 |
| NIH Device Record Key | 575cfc95-0691-401f-abaf-678d37ffd007 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TEST1 2.0 |
| Version Model Number | TEST1 2.0 |
| Catalog Number | SI 195.210/THL |
| Company DUNS | 435930630 |
| Company Name | ALIFAX SRL |
| 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08056040148945 [Primary] |
| GKB | Device, Automated Sedimentation Rate |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-21 |
| Device Publish Date | 2022-10-13 |
| 08056040148778 - LIGHT SCATTERING TEST KIT | 2022-10-28 |
| 08056040148945 - TEST1 2.0 | 2022-10-21 |
| 08056040148945 - TEST1 2.0 | 2022-10-21 |
| 08056040140024 - LATEX CONTROLS | 2022-10-14 |
| 08056040140031 - LATEX CONTROLS | 2022-10-14 |
| 08056040140048 - LATEX CALIBRATORS | 2022-10-14 |
| 08056040140086 - URO-QUICK SCREENING KIT | 2022-10-14 |
| 08056040140291 - ALFRED 60 | 2022-10-14 |
| 08056040140307 - HB&L UROQUATTRO | 2022-10-14 |