| Primary Device ID | 00628063400911 |
| NIH Device Record Key | 67c8702c-6fc2-4c3f-bab8-d02f1f1eaf0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRIGLYCERIDE |
| Version Model Number | SK236-10 |
| Catalog Number | SK236-10 |
| Company DUNS | 966812344 |
| Company Name | SEKISUI DIAGNOSTICS, LLC |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628063400911 [Primary] |
| GS1 | 10628063400918 [Unit of Use] |
| CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-20 |
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