NovaLisa Influenza Virus B IgG INFG0300

GUDID ENTIINFG03000

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

Gold Standard Diagnostics Frankfurt GmbH

Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device IDENTIINFG03000
NIH Device Record Key972ba165-1d16-4a1a-b794-58c7b5aec71e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaLisa Influenza Virus B IgG
Version Model NumberINFG0300
Catalog NumberINFG0300
Company DUNS330328514
Company NameGold Standard Diagnostics Frankfurt GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCENTIINFG03000 [Primary]

FDA Product Code

GNWAntisera, Cf, Influenza Virus A, B, C

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-10
Device Publish Date2024-08-26

On-Brand Devices [NovaLisa Influenza Virus B IgG]

ENTIINFG0300The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antib
ENTIINFG03000The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antib

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