Identity
- Trade Name
- Sunquest CoPathPlus FDA UDI
- Generic Name
- Pathology information system application software FDA UDI
- Device Name
- Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information.. FDA UDI
- Model / Reference
- 7.1 FDA UDI
- Description
- Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information.. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B236CPP7100 FDA UDI
- FDA Product Code
- NVV FDA UDI
- GMDN Term
- Pathology 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 CoPathPlus 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CliniSys, Inc
Sources (1)
- FDA UDI 287e6846-091e-4c8f-8ee4-df57ef4e5de0 34 fields · synced Jun 8, 2026