Identity
- Trade Name
- Sunquest Laboratory FDA UDI
- Generic Name
- Clinical laboratory information system application software FDA UDI
- Device Name
- Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. 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 FDA UDI
- Model / Reference
- 10.1 FDA UDI
- Description
- Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B236LAB10100 FDA UDI
- FDA Product Code
- JQP FDA UDI
- GMDN Term
- Clinical laboratory information system application software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sunquest Laboratory by CliniSys, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CliniSys, Inc
Sources (1)
- FDA UDI 9be3c5ee-795d-4cdc-a980-b4c0b9b4a0cd 34 fields · synced Jun 8, 2026