NovaLisa Adenovirus IgG ADVG0010

GUDID ENTIADVG00100

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

Gold Standard Diagnostics Frankfurt GmbH

Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: ENTIADVG00100
• NIH Device Record Key: 7e028c23-b908-43ae-99ac-f0b6913af724
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaLisa Adenovirus IgG
• Version Model Number: ADVG0010
• Catalog Number: ADVG0010
• Company DUNS: 330328514
• Company Name: Gold Standard Diagnostics Frankfurt GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com
• Phone: +1(888)977-4739
• Email: GSD.TechSupport@us.goldstandarddiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ENTIADVG00100 [Primary]

FDA Product Code

• GNY: Antisera, Fluorescent, Adenovirus 1-33

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-10
• Device Publish Date: 2024-08-26

On-Brand Devices [NovaLisa Adenovirus IgG]

• ENTIADVG0010: The Adenovirus IgG ELISA is intended for the qualitative determination of IgG class antibodies a
• ENTIADVG00100: The Adenovirus IgG ELISA is intended for the qualitative determination of IgG class antibodies a