Synovasure® Alpha Defensin

Basic Information

• Brand Name: Synovasure® Alpha Defensin
• Primary DI: 00887868540684
• Version / Model: 00-8888-125-30
• Catalog Number: 00-8888-125-30
• Company Name: CD DIAGNOSTICS, INC.
• Labeler DUNS: 027871090
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2022-02-04
• Public Version: 5
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: 3feeb939-3dd4-48c2-93ec-21f73e845662

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
QGN	Lateral flow immunochromatography assay for host infection biomarkers	Microbiology	866.3230	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61602	Alpha defensin IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of alpha defensin in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect indirect markers of infection and/or inflammation. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887868540684	GS1
Unit of Use	70887868540683	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN180032	000
K212204	000