| Primary Device ID | 15099590070441 |
| NIH Device Record Key | ea5b658e-25ee-4166-af5b-58793558cf1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AU |
| Version Model Number | ODC0019 |
| Company DUNS | 985071975 |
| Company Name | BECKMAN COULTER IRELAND INC. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15099590070441 [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 | 2016-09-24 |
| 15099590666361 | Urine CSF Albumin Calibrator |
| 15099590635602 | Lyophilized Chemistry Calibrator Level 1 |
| 15099590635572 | Lyophilized Chemistry Calibrator Level 2 |
| 15099590131180 | SYSTEM CALIBRATOR |
| 15099590070441 | BICARBONATE CALIBRATOR |
| 15099590012120 | HbA1c Advanced |
| 15099590010645 | MICROALBUMIN |
| 15099590010607 | α-1 ANTITRYPSIN |
| 15099590010591 | α-1 Acidglycoprotein |