Identity
- Trade Name
- Clinisys Atlas FDA UDI
- Generic Name
- Clinical laboratory information system application software FDA UDI
- Device Name
- Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform. • Clinisys Physician Portal • Clinisys Advanced EMR Connectivity • Clinisys Patient Service Center (PSC) Portal • Clinisys Multi-Lab Networking FDA UDI
- Model / Reference
- 2023.1 FDA UDI
- Description
- Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform. • Clinisys Physician Portal • Clinisys Advanced EMR Connectivity • Clinisys Patient Service Center (PSC) Portal • Clinisys Multi-Lab Networking FDA UDI
Identifiers
- Primary DI / UDI-DI
- B236ATL2023100 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
- 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
Category: Clinical laboratory information system application software
Clinisys Atlas by CliniSys, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 e8797a68-aa2a-4b55-9470-277a5c288d90 33 fields · synced May 30, 2026