| Primary Device ID | 00850201006130 |
| NIH Device Record Key | 7b74507d-8379-41ec-8fa2-a9de6d517527 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LAtrol ABNORMAL CONTROL PLASMA |
| Version Model Number | 816A |
| Catalog Number | 816A |
| Company DUNS | 080600606 |
| Company Name | Biomedica ADI Inc. |
| Device Count | 10 |
| 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 | 00850201006130 [Primary] |
| GS1 | 10850201006137 [Unit of Use] |
| GGC | CONTROL, PLASMA, ABNORMAL |
| 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 | 2016-09-20 |
| 00850201006017 - DVVtest 10 | 2018-03-29 |
| 00850201006024 - DVVconfirm 5 | 2018-03-29 |
| 00850201006031 - ACTICHROME Heparin (Anti-FIIa) | 2018-03-29 |
| 00850201006048 - IMUBIND PLASMA PAI-1 ELISA | 2018-03-29 |
| 00850201006055 - ACTICLOT dPT | 2018-03-29 |
| 00850201006062 - DVVtest 25 | 2018-03-29 |
| 00850201006079 - ACTICHROME HEPARIN (ANTI-FXA) | 2018-03-29 |
| 00850201006086 - ACTICHROME ATIII KIT | 2018-03-29 |