E. coli reference strain O79

Basic Information

• Brand Name: E. coli reference strain O79
• Primary DI: 05713106820643
• Version / Model: 82064
• Catalog Number: 82064
• Company Name: Ssi Diagnostica A/S
• Labeler DUNS: 305684449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-01
• Public Version: 1
• Public Version Date: 2021-08-09
• Public Version Status: New
• Public Device Record Key: 442e61a7-89a4-4866-97c4-7bd83b91bf52

Device Description

Reference strain

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
GMZ	ANTIGENS, ALL TYPES, ESCHERICHIA COLI	Microbiology	866.3255	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50952	Escherichia coli antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713106820643	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 8 – 25 Degrees Celsius