E. coli O46 serum high titer, 1 mL

Basic Information

• Brand Name: E. coli O46 serum high titer, 1 mL
• Primary DI: 05713106814031
• Version / Model: 81403
• Catalog Number: 81403
• Company Name: Ssi Diagnostica A/S
• Labeler DUNS: 305684449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-11
• Public Version: 1
• Public Version Date: 2021-08-19
• Public Version Status: New
• Public Device Record Key: 0e98688b-726b-4e50-a5ee-bb2741d1040c

Device Description

Rabbit antiserum, High titer

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
GNA	ANTISERA, ALL TYPES, ESCHERICHIA COLI	Microbiology	866.3255	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50950	Escherichia coli antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and 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	05713106814031	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius