illumigene Group B Streptococcus External Control Kit

Basic Information

• Brand Name: illumigene Group B Streptococcus External Control Kit
• Primary DI: 00840733101311
• Version / Model: 279900
• Catalog Number: 279900
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Labeler DUNS: 092815364
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2020-07-16
• Public Version Status: Update
• Public Device Record Key: 97c1d670-1183-4d9a-9789-52a14e0468da
• Distribution End Date: 2020-01-18

Device Description

The illumigene GBS External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Group B Streptococcus test kit. External controls are used as part of a routine quality control program.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: 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
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51755	Beta-haemolytic Group B Streptococcus nucleic acid 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 nucleic acid from Group B beta-haemolytic Streptococcus bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840733101311	GS1

Customer Contacts

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

Storage Conditions

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