Phadebact CSF Positive Controls

Basic Information

• Brand Name: Phadebact CSF Positive Controls
• Primary DI: 07350049850238
• Version / Model: 10-5593-12
• Company Name: Mkl Diagnostics AB
• Labeler DUNS: 350472667
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-20
• Public Version: 1
• Public Version Date: 2018-09-20
• Public Version Status: New
• Public Device Record Key: 54da30d5-9cfd-40b5-8769-6b879a1ac1b4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50401	Multiple meningitis-associated bacteria antigen IVD, control	A material which is used to verify the performance of an assay 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. 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	07350049850238	GS1

Storage Conditions

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