NovaLisa Strongyloides STRO0690

GUDID ENTISTRO06900

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

Gold Standard Diagnostics Frankfurt GmbH

Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device IDENTISTRO06900
NIH Device Record Key3e0f84a3-4091-4926-a4b3-9e7d9ce7fb3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaLisa Strongyloides
Version Model NumberSTRO0690
Catalog NumberSTRO0690
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
HIBCCENTISTRO06900 [Primary]

FDA Product Code

MDTElisa, Trichinella Spiralis

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 Date2024-08-27

On-Brand Devices [NovaLisa Strongyloides]

ENTISTRO0690The Strongyloides ELISA is intended for the qualitative determination of antibodies against Stro
ENTISTRO06900The Strongyloides ELISA is intended for the qualitative determination of antibodies against Stro

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