Wellcogen S pneumoniae

Basic Information

• Brand Name: Wellcogen S pneumoniae
• Primary DI: 05056080501581
• Version / Model: R30859001
• Company Name: REMEL EUROPE LIMITED
• Labeler DUNS: 232600853
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-21
• Public Version: 1
• Public Version Date: 2021-07-29
• Public Version Status: New
• Public Device Record Key: 42bd0337-791d-486a-9f41-bfcf440e3372

Device Characteristics

• Single Use: No
• 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: No
• 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
50399	Multiple meningitis-associated bacteria antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple bacteria associated with meningitis, in a clinical specimen, using an agglutination method. Bacteria detected may include Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B streptococcus or Escherichia coli (E. coli) bacteria.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05056080501581	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K841376	000