| Primary Device ID | 07070060012889 |
| NIH Device Record Key | 13dcc273-f7f5-4aeb-8624-55031ce58257 |
| Commercial Distribution Discontinuation | 2018-11-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Afinion HbA1c Dx |
| Version Model Number | 1116482 |
| Catalog Number | 1116482 |
| Company DUNS | 515324122 |
| Company Name | Abbott Diagnostics Technologies AS |
| 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 | true |
| 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07070060012889 [Primary] |
| PDJ | Hemoglobin A1c Test System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-05-09 |
| Device Publish Date | 2018-11-01 |
| 07070060012889 | Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood |
| 07070060014555 | Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in human whole blood i |