| Primary Device ID | 03610230008508 |
| NIH Device Record Key | bf5c834d-d1a3-4ad2-b4c2-0744102df623 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Yumizen SPS |
| Version Model Number | 1300032346 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 03610230008508 [Primary] |
| KPA | Slide Stainer, Automated |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-07 |
| Device Publish Date | 2024-05-30 |
| 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 |
| 03610230009581 - ABX Minotrol 16 | 2024-10-03 |
| 03610230009598 - ABX Minotrol 16 | 2024-10-03 |
| 03610230009604 - ABX Minotrol 16 | 2024-10-03 |
| 03610230005545 - ABX PENTRA CK CONTROL | 2024-07-18 |