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

EUROLabOffice 4.0

Name: EUROLabOffice 4.0
Brand: EUROLabOffice 4.0

Catalogue number YG 0250-0101-7, listed by Euroimmun Medizinische Labordiagnostika AG, Germany, under Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System. 1 manufacturer in China is registered for this product code.

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 EUROLabOffice 4.0
Listed by	Euroimmun Medizinische Labordiagnostika AG, Germany
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	Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2022-12-08

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for EUROLabOffice 4.0
Catalogue number	Size	Status
YG 0250-0101-7		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
Ultra Laboratory Information System	Cirdan Imaging Limited	1
Sunquest VUE	CliniSys, Inc	1
Clinisys CoPathPlus	CliniSys, Inc	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.