E. coli H43 serum, 5 mL

Basic Information

• Brand Name: E. coli H43 serum, 5 mL
• Primary DI: 05713106544617
• Version / Model: 54461
• Catalog Number: 54461
• 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: 469ac6f5-727b-4b54-b515-a87ee3e658a7

Device Description

Rabbit antiserum, Ready to use

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	05713106544617	GS1

Customer Contacts

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

Storage Conditions

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