Nova Primary

Basic Information

• Brand Name: Nova Primary
• Primary DI: 00385480634571
• Version / Model: Nova Primary Analyzer
• Catalog Number: 63457
• Company Name: NOVA BIOMEDICAL CORPORATION
• Labeler DUNS: 070617139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-08
• Public Version: 1
• Public Version Date: 2023-02-16
• Public Version Status: New
• Public Device Record Key: fc2d4904-18ec-4a24-9474-fc20168c35fc

Device Description

Nova Primary Glucose Analyzer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56686	Glucose analyser IVD, laboratory, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood, serum, plasma and/or other body fluid.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10385480634578	GS1		1	In Commercial Distribution
Primary	00385480634571	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K203549	000