NovaLisa Influenza Virus A IgG INFG0290

GUDID ENTIINFG02900

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

Gold Standard Diagnostics Frankfurt GmbH

Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: ENTIINFG02900
• NIH Device Record Key: f9d01e6e-5eb2-402e-a3aa-439e155f6e23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaLisa Influenza Virus A IgG
• Version Model Number: INFG0290
• Catalog Number: INFG0290
• 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	ENTIINFG02900 [Primary]

FDA Product Code

• GNW: Antisera, Cf, Influenza Virus A, B, C

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 Influenza Virus A IgG]

• ENTIINFG0290: The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antib
• ENTIINFG02900: The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antib