| Primary Device ID | 00628063401178 |
| NIH Device Record Key | 4efbaf26-168f-4d9f-a820-e30188d81a86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HbA1c Blank Solution |
| Version Model Number | SK350-BLK |
| Catalog Number | SK350-BLK |
| Company DUNS | 966812344 |
| Company Name | SEKISUI DIAGNOSTICS, LLC |
| Device Count | 2 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628063401178 [Primary] |
| GS1 | 10628063401175 [Unit of Use] |
| JIT | Calibrator, secondary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| 00628063401291 - Acetaminophen | 2023-05-16 |
| 00628063401307 - Acetaminophen Calibrator | 2023-05-16 |
| 00628063401314 - Alinity c Acetaminophen | 2023-05-16 |
| 00628063401321 - Alinity c Acetaminophen Calibrator | 2023-05-16 |
| 10742860100397 - OSOM ULTRA PLUS FLU A&B Test | 2022-06-10 |
| 00628063401222 - DC-TROL LEVELS 1 & 2 | 2020-04-07 |
| 00628063400003 - Carbon Dioxide L3K | 2019-10-21 |
| 00628063400287 - CARBON DIOXIDE L3K Assay | 2019-10-21 |