NovaLisa Brucella IgG BRUG0050

GUDID ENTIBRUG00500

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

Gold Standard Diagnostics Frankfurt GmbH

Multiple Brucella species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device IDENTIBRUG00500
NIH Device Record Key8abd9d50-7457-4628-b64e-2472199e989a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaLisa Brucella IgG
Version Model NumberBRUG0050
Catalog NumberBRUG0050
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
HIBCCENTIBRUG00500 [Primary]

FDA Product Code

GSMAntisera, Fluorescent, Brucella Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-03
Device Publish Date2024-08-26

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