Clinisys SQ Lab
Basic Information
- Brand Name
- Clinisys SQ Lab
- Primary DI
- B236SQLAB11030
- Version / Model
- 11.0.3
- Company Name
- CliniSys, Inc
- Labeler DUNS
- 052934841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-10
- Public Version
- 1
- Public Version Date
- 2024-03-18
- Public Version Status
- New
- Public Device Record Key
- 2de9ced5-1ccc-4f7f-a5b6-eb989220bd60
Device Description
Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory. Clinisys SQ Lab is intended for use only by professionals who have received extensive training in the use of the software. Clinisys SQ Lab is controlled via user defined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | Clinical Chemistry | 862.2100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44082 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B236SQLAB11030 | HIBCC |