Mycoplasma genitalium macrolide resistance probes

Basic Information

• Brand Name: Mycoplasma genitalium macrolide resistance probes
• Primary DI: 15430001412076
• Version / Model: 1
• Company Name: Diagenode
• Labeler DUNS: 373050462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-15
• Public Version: 1
• Public Version Date: 2021-03-23
• Public Version Status: New
• Public Device Record Key: 73c40cd5-75d0-43bb-902c-1ab53b32f741

Device Description

Oligunucleotides designed to detect mutations associated to macrolide resistance on 23S RNA (A2058C, 2058G, 2058T, 2059C, A2059G). These oligonucleotides contain a 5' FAM label and a 3' BHQ-1 label

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
47324	Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Mycoplasma genitalium bacteria in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15430001412076	GS1