Clinisys Laboratory Solution
- Primary DI
- B236CLS202520
- Brand
- Clinisys Laboratory Solution
- Company
- CliniSys, Inc
- Model
- 2025.2
- Device description
- The Clinisys Laboratory Solution (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.
- Published
- 2025-11-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | Clinical Chemistry | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B236CLS202520 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Clinical laboratory information system application software | An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks. |
Regulatory Flags#
- DUNS number
- 052934841
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B236CPP8030 | Clinisys CoPathPlus | 8.0.3 | 2026-02-18 | |
| B236SQBB202420 | Clinisys SQ Blood Bank | 2024.2 | 2026-01-23 | |
| B236SQLAB202420 | Clinisys SQ Lab | 2024.2 | 2026-01-23 | |
| B236CATL202510 | Clinisys Atlas | 2025.1 | 2026-01-06 | |
| B236CLS202510 | Clinisys Laboratory Solution | 2025.1 | 2025-08-13 | |
| B236CATL202350 | Clinisys Atlas | 2023.5 | 2025-07-11 | |
| B236BB10110 | Sunquest Blood Bank | 10.1.1 | 2022-03-22 | |
| B236LAB10110 | Sunquest Laboratory | 10.1.1 | 2022-03-22 | |
| B236BB10010 | Sunquest Blood Bank | 10.0.1 | 2021-03-05 | |
| B236LAB10010 | Sunquest Laboratory | 10.0.1 | 2021-03-05 | |
| B236BB8010 | Sunquest Blood Bank | 8.0.1 | 2021-02-19 | |
| B236BB8130 | Sunquest Blood Bank | 8.1.3 | 2021-02-19 | |
| B236BB8230 | Sunquest Blood Bank | 8.2.3 | 2021-02-19 | |
| B236LAB8010 | Sunquest Laboratory | 8.0.1 | 2021-02-19 | |
| B236LAB8130 | Sunquest Laboratory | 8.1.3 | 2021-02-19 | |
| B236LAB8230 | Sunquest Laboratory | 8.2.3 | 2021-02-19 | |
| B236SQBB202410 | Clinisys SQ Blood Bank | 2024.1 | 2024-12-06 | |
| B236SQLAB202410 | Clinisys SQ Lab | 2024.1 | 2024-12-06 | |
| B236CATL202340 | Clinisys Atlas | 2023.4 | 2024-11-27 | |
| B236CLS202330 | Clinisys Laboratory Solution | 2023.3 | 2024-10-25 |
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| 00810142374033 | SoftGenomics | SCC SOFT COMPUTER | JQP | 2026-04-16 |
| 00810142374040 | SoftTrack | SCC SOFT COMPUTER | JQP | 2026-04-16 |
| 00810142373586 | SoftTotalQC | SCC SOFT COMPUTER | JQP | 2026-03-28 |
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| 00810142373722 | SoftCytogenetics | SCC SOFT COMPUTER | JQP | 2026-03-12 |
| 00810142373739 | SoftPathDx | SCC SOFT COMPUTER | JQP | 2026-03-12 |
| 00810142373746 | SoftFlowCytometry | SCC SOFT COMPUTER | JQP | 2026-03-12 |
| 00810142373753 | SoftHLA | SCC SOFT COMPUTER | JQP | 2026-03-12 |
| 00810142373760 | SoftMolecular | SCC SOFT COMPUTER | JQP | 2026-03-12 |
| 00810142373777 | SoftGenomics | SCC SOFT COMPUTER | JQP | 2026-03-12 |
| 00810142373784 | SoftTrack | SCC SOFT COMPUTER | JQP | 2026-03-12 |
| 00810142373340 | SoftTotalQC | SCC SOFT COMPUTER | JQP | 2026-03-11 |
| 00810142373593 | SoftBiochemistry | SCC SOFT COMPUTER | JQP | 2026-02-21 |
| 00810142373609 | SoftCytogenetics | SCC SOFT COMPUTER | JQP | 2026-02-21 |
| 00810142373616 | SoftPathDx | SCC SOFT COMPUTER | JQP | 2026-02-21 |
| 00810142373623 | SoftFlowCytometry | SCC SOFT COMPUTER | JQP | 2026-02-21 |
| 00810142373630 | SoftHLA | SCC SOFT COMPUTER | JQP | 2026-02-21 |
| 00810142373647 | SoftMolecular | SCC SOFT COMPUTER | JQP | 2026-02-21 |
| 00810142373654 | SoftGenomics | SCC SOFT COMPUTER | JQP | 2026-02-21 |
| 00810142373661 | SoftTrack | SCC SOFT COMPUTER | JQP | 2026-02-21 |
| 00810142373500 | SoftBiochemistry | SCC SOFT COMPUTER | JQP | 2026-02-04 |
| 00810142373517 | SoftCytogenetics | SCC SOFT COMPUTER | JQP | 2026-02-04 |
| 00810142373524 | SoftPathDx | SCC SOFT COMPUTER | JQP | 2026-02-04 |