MASTALEX-MRSA RST501

GUDID 15060392372705

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

MAST GROUP LIMITED

Staphylococcus aureus culture isolate identification/methicillin susceptibility testing IVD, kit Staphylococcus aureus culture isolate identification/methicillin susceptibility testing IVD, kit

• Primary Device ID: 15060392372705
• NIH Device Record Key: 70e5c216-897a-4e1d-9679-2bc5cd7e5bc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTALEX-MRSA
• Version Model Number: RST501
• Catalog Number: RST501
• Company DUNS: 212623821
• Company Name: MAST GROUP LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060392372705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062864

FDA Product Code

• MYI: System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-02

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