| Primary Device ID | 03610230008232 |
| NIH Device Record Key | f1edd17c-7918-43aa-8489-dc5d3327dcfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ABX Pentra Micro ALB 2 Cal |
| Version Model Number | 1300032565 |
| Company DUNS | 273647420 |
| Company Name | HORIBA ABX SAS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03610230008232 [Primary] |
| DCF | Albumin, Antigen, Antiserum, Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-08-18 |
| Device Publish Date | 2017-07-07 |
| 03610230005774 - ABX PENTRA MICRO-ALB CAL | 2025-08-18 |
| 03610230005781 - ABX PENTRA MICRO ALB CONTROL L/H | 2025-08-18 |
| 03610230008232 - ABX Pentra Micro ALB 2 Cal | 2025-08-18 |
| 03610230008232 - ABX Pentra Micro ALB 2 Cal | 2025-08-18 |
| 03610230008966 - Yumizen P8000 | 2025-07-15 1 connexion |
| 03610230009444 - Yumizen H2500 | 2024-12-09 |
| 03610230009451 - Yumizen H2500 | 2024-12-09 |
| 03610230009611 - ABX Minocal | 2024-10-07 |
| 03610230008584 - BFTROL | 2024-10-04 BF Hematology control |