What is FDA product code NVV?

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.

Clinical Chemistry › Laboratory InstrumentsDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

Ultra Laboratory Information System

Name: Ultra Laboratory Information System
Brand: Ultra Laboratory Information System

Digital image, storage and communication, non-diagnostic, laboratory information system

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code NVV
Manufacturer	City	Province	Registered as	Device types
Hangzhou Diagens Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	2

Record

Regulatory record for Ultra Laboratory Information System
Listed by	Cirdan Imaging Limited, United Kingdom
FDA product code	NVV
Device type	Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
Device class	Class 1
Regulation	21 CFR 862.2100
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2019-10-08
Record revised	2026-06-09 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for Ultra Laboratory Information System
Catalogue number	Size	Status
4.7, 4.8, 4.9		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
SoftMedia	SCC Soft Computer	14
Sunquest PowerPath	CliniSys, Inc	2
Sunquest CoPathPlus	CliniSys, Inc	2
Imaging System HIS-5000U	Huvitz Co., Ltd.	1
Sunquest VUE	CliniSys, Inc	1
Clinisys CoPathPlus	CliniSys, Inc	1
EUROLabOffice 4.0	Euroimmun Medizinische Labordiagnostika AG	1
CyberLAB	Aspyra, LLC.	1
Sentinel	Vistapath Biosystems Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.