AAV5 DetectCDx

Basic Information

• Brand Name: AAV5 DetectCDx
• Primary DI: 00860007476815
• Version / Model: PD-0008-F0036
• Company Name: ARUP Laboratories, Inc
• Labeler DUNS: 117513135
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-22
• Public Version: 1
• Public Version Date: 2025-05-30
• Public Version Status: New
• Public Device Record Key: 1e27bfb4-ff9a-49d7-b33c-345ea02527dd

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

GMDN Terms

Code	Name	Definition	Implantable	Status
58793	Chemiluminescent immunoassay signal generation kit IVD	A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an immunoassay on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled antibodies or antigens of known characterization and may also include reference material to optimise and verify performance of the luminometer instrument.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007476815	GS1