Nova Primary 63457

GUDID 10385480634578

Nova Primary Glucose Analyzer

NOVA BIOMEDICAL CORPORATION

Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated Glucose analyser IVD, laboratory, automated/semi-automated
Primary Device ID10385480634578
NIH Device Record Keyfc2d4904-18ec-4a24-9474-fc20168c35fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameNova Primary
Version Model NumberNova Primary Analyzer
Catalog Number63457
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100385480634571 [Primary]
GS110385480634578 [Package]
Contains: 00385480634571
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGLUCOSE OXIDASE, GLUCOSE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-16
Device Publish Date2023-02-08

On-Brand Devices [Nova Primary]

10385480634578Nova Primary Glucose Analyzer
00385480631624Nova Primary Calibrator Cartridge 450 Sample
00385480632317Nova Primary Glucose Sensor
00385480631679Nova Primary Calibrator Cartridge 150 Sample
00385480632300Nova Primary Glucose Membrane
00385480631662Nova Primary Linearity Level 2
00385480631655Nova Primary Linearity Level 1
00385480631648Nova Primary Ampuled Control 1, 2
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