| Primary Device ID | B236LIMS3500 |
| NIH Device Record Key | 7b6b327c-42ce-4df9-ab97-4eb3f3d573ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sunquest Mitogen LIMS |
| Version Model Number | 3.5 |
| Company DUNS | 052934841 |
| Company Name | SUNQUEST INFORMATION SYSTEMS, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
|---|---|
| HIBCC | B236LIMS3500 [Primary] |
| JQP | Calculator/Data Processing Module, For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-12 |
| Device Publish Date | 2021-07-02 |
| B236LIMS3300 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow |
| B236LIMS3400 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow |
| B236LIMS3500 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow |
| B236LIMS4000 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow |
| B236LIMS4100 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow |