Phadebact Monoclonal GC Test

Basic Information

• Brand Name: Phadebact Monoclonal GC Test
• Primary DI: 07350049850269
• Version / Model: 10-6419-12
• Catalog Number: 10-6419-12
• Company Name: Mkl Diagnostics AB
• Labeler DUNS: 350472667
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 08e2556a-48fe-42b5-904c-44941e69f566

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
LIC	Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae	Microbiology	866.3390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51230	Neisseria gonorrhoeae 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 Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea, in a clinical specimen using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350049850269	GS1

Customer Contacts

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

Storage Conditions

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