| Primary Device ID | 04987503563002 |
| NIH Device Record Key | 75a87d4f-816d-480d-8082-b2288f950a48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lipid Calibrator S |
| Version Model Number | 563002 |
| Company DUNS | 694830238 |
| Company Name | DENKA SEIKEN CO., LTD. |
| 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 | true |
| 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 |
| Phone | +1 408-371-8819 |
| xx@xx.xx | |
| Phone | +1 408-371-8819 |
| xx@xx.xx | |
| Phone | +1 408-371-8819 |
| xx@xx.xx | |
| Phone | +1 408-371-8819 |
| xx@xx.xx | |
| Phone | +1 408-371-8819 |
| xx@xx.xx | |
| Phone | +1 408-371-8819 |
| xx@xx.xx | |
| Phone | +1 408-371-8819 |
| xx@xx.xx |
| Special Storage Condition, Specify | Between 0 and 0 *shading |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *shading |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *shading |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *shading |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *shading |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *shading |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *shading |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987503563002 [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 | 2018-07-30 |
| Device Publish Date | 2018-06-29 |
| 04987503562760 - s LDL-EX "SEIKEN" | 2019-10-21 |
| 04987503562791 - s LDL-EX "SEIKEN" | 2019-10-21 |
| 04987503562807 - s LDL-EX "SEIKEN" | 2019-10-21 |
| 04987503563002 - Lipid Calibrator S | 2018-07-30 |
| 04987503563002 - Lipid Calibrator S | 2018-07-30 |
| 04987503563019 - Lipid Control S-Ⅰ | 2018-07-30 |
| 04987503563026 - Lipid Control S-Ⅱ | 2018-07-30 |