ImmuLex Pneumococcus Pool E serum, 1.5 mL

Basic Information

• Brand Name: ImmuLex Pneumococcus Pool E serum, 1.5 mL
• Primary DI: 05713106523940
• Version / Model: 52394
• Catalog Number: 52394
• Company Name: Ssi Diagnostica A/S
• Labeler DUNS: 305684449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-25
• Public Version: 1
• Public Version Date: 2021-08-02
• Public Version Status: New
• Public Device Record Key: bb5ac216-77ca-44db-b463-59d10869f00c

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
GWC	ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51772	Streptococcus pneumoniae culture isolate antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from Streptococcus pneumoniae bacteria isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713106523940	GS1

Customer Contacts

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

Storage Conditions

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