StatStrip

Basic Information

• Brand Name: StatStrip
• Primary DI: 00385480421737
• Version / Model: Statstrip/StatStrip Xpress
• Catalog Number: 42173
• Company Name: NOVA BIOMEDICAL CORPORATION
• Labeler DUNS: 070617139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 82a7bf05-d5f5-4c20-8196-732e59b0df25

Device Description

StatStrip StatStrip Xpress GLU Linearity Level 1-5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385480421737	GS1
Unit of Use	00385489421738	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150461	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze
• Type: Special Storage Condition, Specify
• Special Conditions: Do not refrigerate