URO-QUICK RAA KIT

Basic Information

• Brand Name: URO-QUICK RAA KIT
• Primary DI: 08056040141281
• Version / Model: URO-QUICK RAA KIT
• Catalog Number: SI 390.901
• Company Name: ALIFAX SRL
• Labeler DUNS: 435930630
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-06
• Public Version: 1
• Public Version Date: 2022-10-14
• Public Version Status: New
• Public Device Record Key: be26f105-02be-4a26-a31a-65e4f1724465

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
JTA	Monitor, Microbial Growth	Microbiology	866.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58537	Antimicrobial activity testing agar culture medium IVD	A nutrient agar culture medium intended to be used for seeding a standard bacterial isolate to detect or monitor residual antimicrobial activity present in a clinical specimen, as shown by its ability to inhibit growth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056040141281	GS1

Storage Conditions

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