| Primary Device ID | 03610230007457 |
| NIH Device Record Key | a8cd31a9-4672-4c76-952e-ba0628770790 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Yumizen C1200 Protein Cal |
| Version Model Number | 1300023893 |
| 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 | 03610230007457 [Primary] |
| JIX | Calibrator, Multi-Analyte Mixture |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-07 |
| Device Publish Date | 2020-08-28 |
| 03610230004890 - ABX PENTRA ALP CP | 2023-07-06 |
| 03610230004913 - ABX PENTRA AMYLASE CP | 2023-07-06 |
| 03610230004920 - ABX PENTRA AST CP | 2023-07-06 |
| 03610230004937 - ABX PENTRA GGT CP | 2023-07-06 |
| 03610230004944 - ABX PENTRA LIPASE CP | 2023-07-06 |
| 03610230004975 - ABX PENTRA CHOLESTEROL CP | 2023-07-06 |
| 03610230004982 - ABX PENTRA BILIRUBIN, DIRECT CP | 2023-07-06 |
| 03610230004999 - ABX PENTRA HDL DIRECT CP | 2023-07-06 |