Simplexa™ C. auris Sample Prep Kit

Basic Information

• Brand Name: Simplexa™ C. auris Sample Prep Kit
• Primary DI: 20816101027235
• Version / Model: MOL5390
• Catalog Number: MOL5390
• Company Name: DIASORIN MOLECULAR LLC
• Labeler DUNS: 080271715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-19
• Public Version: 2
• Public Version Date: 2024-08-23
• Public Version Status: Update
• Public Device Record Key: f9e3ff79-e6cc-4036-8f28-27c8089bf214

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
SBT	Device To Detect Microbial Colonization Directly From Clinical Specimens.	Microbiology	866.3967	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65248	Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from the yeast Candida auris in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20816101027235	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN230092	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -10 Degrees Celsius