| Primary Device ID | 15099590012120 |
| NIH Device Record Key | b0cf24b8-d07d-49a8-9da8-5ab20d106480 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AU |
| Version Model Number | B93009 |
| 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2 to 8 degrees celcius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2 to 8 degrees celcius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15099590012120 [Primary] |
| PDJ | Hemoglobin A1c Test System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-13 |
| 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 |