FDA UDI
In Commercial Distribution
🇺🇸 United States
POC Controller
DI: 03770035155064
·
Model: 1
·
BYG INFORMATIQUE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- POC Controller
- Primary DI
- 03770035155064
- Version / Model
- 1
- Company Name
- BYG INFORMATIQUE
- Labeler DUNS
- 390482891
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-30
- Public Version
- 1
- Public Version Date
- 2026-02-09
- Public Version Status
- New
- Public Device Record Key
- 24036cb2-3cb6-4d56-8619-ea5d7663bd9f
Device Description
POC Controller is a software middleware intended for use by laboratory professionals in single-site and multi-site clinical laboratories performing in vitro diagnostic point-of-care testing. The software is designed to automate the acquisition, consolidation, supervision, and transfer of data between POCT instruments (IVD) and Laboratory Information Systems (LIS), POC Controller enables instruments mapping, real-time data centralization, supervise staff skill certifications across one or multiple clinical departments and laboratories. The device does not perform biological sample analysis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | Clinical Chemistry | 862.2100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44082 | Clinical laboratory information system application software | An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03770035155064 | GS1 |