NovaLisa Adenovirus IgG

Basic Information

• Brand Name: NovaLisa Adenovirus IgG
• Primary DI: ENTIADVG00100
• Version / Model: ADVG0010
• Catalog Number: ADVG0010
• Company Name: Gold Standard Diagnostics Frankfurt GmbH
• Labeler DUNS: 330328514
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-26
• Public Version: 2
• Public Version Date: 2024-09-10
• Public Version Status: Update
• Public Device Record Key: 7e028c23-b908-43ae-99ac-f0b6913af724

Device Description

The Adenovirus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Adenovirus in human serum or plasma (citrate, heparin).

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: 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
GNY	Antisera, Fluorescent, Adenovirus 1-33	Microbiology	866.3020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49869	Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Adenovirus in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	ENTIADVG00100	HIBCC

Customer Contacts

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

Storage Conditions

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