Pneumococcus CWPS, 10 mg

Basic Information

• Brand Name: Pneumococcus CWPS, 10 mg
• Primary DI: 05713106034590
• Version / Model: 3459
• Catalog Number: 3459
• 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: c469f1ae-01c9-43b4-add1-c8a7bce2bd1a

Device Description

Cell wall polysaccharide

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
MVU	Reagents, specific, analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64703	Streptococcus pneumoniae total antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Streptococcus pneumoniae bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713106034590	GS1

Customer Contacts

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

Storage Conditions

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