mecA XpressFISH®

Basic Information

• Brand Name: mecA XpressFISH®
• Primary DI: 00812125010082
• Version / Model: KT601
• Catalog Number: KT601
• Company Name: ADVANDX, INC.
• Labeler DUNS: 145416900
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-08
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2bebb95a-b532-4150-bc4a-55d8ff991392

Device Description

25 tests per kit

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
MYI	SYSTEM,TEST,GENOTYPIC DETECTION,RESISTANT MARKERS,STAPHYLOCOCCUS COLONIES	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51662	Staphylococcus aureus culture isolate antigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from Staphylococcus aureus bacteria isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812125010082	GS1

Customer Contacts

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

Storage Conditions

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