| Primary Device ID | 05055845400169 |
| NIH Device Record Key | 9f0cd5a6-17f2-4978-8f6c-953710ec3e5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine |
| Version Model Number | FHRWR100 |
| Catalog Number | FHRWR100 |
| Company DUNS | 229062427 |
| Company Name | AXIS-SHIELD DIAGNOSTICS 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 | false |
| 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 | +441382422000 |
| MDL-AXD-Product-Support@alere. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055845400169 [Primary] |
| JIT | Calibrator, Secondary |
| 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 | 2016-07-01 |
| 05055845400282 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determi |
| 05055845400183 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determi |
| 05055845400176 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determi |
| 05055845400169 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determi |