| Primary Device ID | 04987503563088 |
| NIH Device Record Key | eeadd4f8-45cc-40dc-bf2a-b0cd48ccc00c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | small dense LDL Control Set |
| Version Model Number | 08834105190 |
| Catalog Number | 08834105190 |
| Company DUNS | 694830238 |
| Company Name | DENKA COMPANY LIMITED |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987503563088 [Primary] |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2020-10-13 |
| 04987503562906 - small dense LDL Seiken | 2024-12-26 |
| 04987503562883 - small dense LDL Seiken | 2020-10-21 |
| 04987503562890 - small dense LDL Seiken | 2020-10-21 |
| 04987503563071 - small dense LDL Calibrator | 2020-10-21 |
| 04987503563088 - small dense LDL Control Set | 2020-10-21 |
| 04987503563088 - small dense LDL Control Set | 2020-10-21 |