| Primary Device ID | 05391521421081 |
| NIH Device Record Key | 615eaf5a-e567-46db-9cb0-291253395b04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Destiny MAX Analyzer |
| Version Model Number | M01000 |
| Company DUNS | 985039126 |
| Company Name | TCOAG IRELAND LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | false |
| 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 | 05391521421081 [Primary] |
| JPA | System, Multipurpose For In Vitro Coagulation Studies |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-12 |
| 15391521421286 - TriniLIZE™ Stabilyte tubes | 2019-07-19 |
| 15391521420470 - TriniCLOT Lupus Screen | 2019-07-08 |
| 15391521420487 - TriniCLOT Lupus Confirm | 2019-07-08 |
| 15391521420630 - TriniCHECK Level 1 | 2019-07-08 |
| 15391521420647 - TriniCHECK Level 2 | 2019-07-08 |
| 15391521420654 - TriniCHECK Level 3 | 2019-07-08 |
| 15391521421309 - DT Wash | 2019-07-08 |
| 15391521421729 - DT Fluid | 2019-07-08 |