| Primary Device ID | 00894472000107 |
| NIH Device Record Key | fe3ed5ef-bb4d-4a8a-9975-372cd9b6c0f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTI Check Control Tri Level |
| Version Model Number | 1 |
| Catalog Number | HC7008 |
| Company DUNS | 801458279 |
| Company Name | OPTI MEDICAL SYSTEMS, INC. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00894472000107 [Primary] |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-12-21 |
| Device Publish Date | 2019-08-06 |
| 00894472000237 - B Cassette | 2022-12-08 B Cassette Carton |
| 00894472000244 - OPTI CCA E Cassette | 2022-12-08 OPTI CCA E Cassette |
| 00894472000251 - E-Ca Cassette Carton | 2022-12-08 E-Ca Cassette |
| 00894472000268 - OPTI CCA E-Cl Cassette | 2022-12-08 OPTI CCA E-Cl Cassette |
| 00894472000275 - OPTI CCA E-Glu Cassette | 2022-12-08 OPTI CCA E-Glu Cassette |
| 00894472000107 - OPTI Check Control Tri Level | 2020-12-21OPTI Check Controls Tri Level |
| 00894472000107 - OPTI Check Control Tri Level | 2020-12-21 OPTI Check Controls Tri Level |
| 00894472000114 - OPTI Check Plus | 2020-12-21 OPTI Check Plus Tri-level controls |