FDA product code NVV

Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

Clinical Chemistry·Class 1·21 CFR 862.2100
US regulatory classifications
US Product Code (FDA)
NVV
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 862.2100
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Intended for clinical laboratory image storage and communications. A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images.

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About this record

Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.