NOVA MAX 43446

GUDID 00385480434461

Nova Max Glucose Normal Glucose Control Solution

NOVA BIOMEDICAL CORPORATION

Glucose IVD, control
Primary Device ID00385480434461
NIH Device Record Keyfeed8865-10e2-4f63-a55b-3c4fc57e1760
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVA MAX
Version Model NumberGLU
Catalog Number43446
Company DUNS070617139
Company NameNOVA BIOMEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)545-6682
Emailinfo@novabio.com
Phone+1(800)545-6682
Emailinfo@novabio.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100385480434461 [Primary]

FDA Product Code

JJXSingle (specified) analyte controls (assayed and unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-20

On-Brand Devices [NOVA MAX]

00385480496407Nova Max Plus Glu/Ket Control Solution - Mid
10385480458242Nova Max Plus Blood Glucose Monitoring System
10385480445853Nova Max Link with Battery and Quick Reference Guide
00385480434461Nova Max Glucose Normal Glucose Control Solution
10385480434369Nova Max Plus Blood Glucose Monitoring System
10385480434352Nova Max Plus Plus Blood Glucose Monitoring System

Trademark Results [NOVA MAX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVA MAX
NOVA MAX
77061335 3436977 Live/Registered
Nova Biomedical Corporation
2006-12-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.