MASTALEX-MRSA

Basic Information

• Brand Name: MASTALEX-MRSA
• Primary DI: 15060392372705
• Version / Model: RST501
• Catalog Number: RST501
• Company Name: MAST GROUP LIMITED
• Labeler DUNS: 212623821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-02
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 70e5c216-897a-4e1d-9679-2bc5cd7e5bc6

Device Description

MASTALEX-MRSA Rapid latex test for the detection of M.R.S.A.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
MYI	System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56290	Staphylococcus aureus culture isolate identification/methicillin susceptibility testing IVD, kit	A collection of reagents and other associated materials intended to be used for the identification of Staphylococcus aureus bacteria isolated from a clinical specimen by culture, and for determining susceptibility of Staphylococcus aureus isolates to the antimicrobial methicillin, to identify methicillin-resistant Staphylococcus aureus (MRSA).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060392372705	GS1

Premarket Submissions

Submission Number	Supplement Number
K062864	000

Storage Conditions

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