Identity
- Trade Name
- SYNCT™ Software FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions. FDA UDI
- Model / Reference
- CN-SW47 FDA UDI
- Description
- The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840487100448 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laboratory instrument/analyser application software IVD
SYNCT™ Software by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152386 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA UDI 8d308d2e-9be3-4241-9f81-e7b03f40f207 35 fields · synced Jun 9, 2026