Identity
- Trade Name
- Sunquest Application Interfacing FDA UDI
- Generic Name
- Clinical laboratory information system application software FDA UDI
- Device Name
- Sunquest Application Interface (AI) is to provide interfaces between client systems and Sunquest products to support laboratories in the management of laboratory workflow (order entry through reporting) and transfer test results and information FDA UDI
- Model / Reference
- 5.3 FDA UDI
- Description
- Sunquest Application Interface (AI) is to provide interfaces between client systems and Sunquest products to support laboratories in the management of laboratory workflow (order entry through reporting) and transfer test results and information FDA UDI
Identifiers
- Primary DI / UDI-DI
- B236AI5300 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Clinical laboratory information system application software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 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 Application Interfacing 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 66f28d63-3cb0-409e-9b64-50415c42943e 34 fields · synced Jun 1, 2026