| Primary Device ID | 05055273200225 |
| NIH Device Record Key | 1ea35b52-7de6-4756-b952-3f415df1e170 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALT |
| Version Model Number | AL3875 |
| Catalog Number | AL3875 |
| Company DUNS | 227530649 |
| Company Name | RANDOX LABORATORIES LIMITED |
| 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 | +442894451070 |
| technical.services@randox.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Reagent is stable for 7 days at +2 to +8ºC |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273200225 [Primary] |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-24 |
| Device Publish Date | 2018-12-24 |
| 05055273200225 | An ALT test system is a device intended for the quantitative in vitro determination of of Alanin |
| 05055273200218 | An ALT test system is a device intended for the quantitative in vitro determination of Alanine A |