mecA XpressFISH® KT601

GUDID 00812125010082

25 tests per kit

ADVANDX, INC.

Staphylococcus aureus culture isolate antigen IVD, reagent

• Primary Device ID: 00812125010082
• NIH Device Record Key: 2bebb95a-b532-4150-bc4a-55d8ff991392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mecA XpressFISH®
• Version Model Number: KT601
• Catalog Number: KT601
• Company DUNS: 145416900
• Company Name: ADVANDX, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(781)376-0009
• Email: techsupport@advandx.com
• Phone: +1(781)376-0009
• Email: techsupport@advandx.com

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	00812125010082 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-08