FDA.reportPublic FDA data

NovaLisa Strongyloides

Primary DI
ENTISTRO0690
Brand
NovaLisa Strongyloides
Company
Gold Standard Diagnostics Frankfurt GmbH
Model
STRO0690
Catalog number
STRO0690
Device description
The Strongyloides ELISA is intended for the qualitative determination of antibodies against Strongyloides in human serum or plasma (citrate or heparin).
Published
2024-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDTElisa, Trichinella Spiralis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDTElisa, Trichinella SpiralisMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENTISTRO0690PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic nematode Strongyloides stercoralis in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)977-4739GSD.TechSupport@us.goldstandarddiagnostics.com

Regulatory Flags#

DUNS number
330328514
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ENTIADVG00100NovaLisa Adenovirus IgGADVG0010ADVG00102024-08-26
ENTIECHG01300NovaLisa Echinococcus IgGECHG0130ECHG01302024-08-26
ENTIENTG01400NovaLisa Entamoeba histolytica IgGENTG0140ENTG01402024-08-26
ENTIINFG02900NovaLisa Influenza Virus A IgGINFG0290INFG02902024-08-26
ENTIINFG03000NovaLisa Influenza Virus B IgGINFG0300INFG03002024-08-26
ENTILEPG06600NovaLisa Leptospira IgGLEPG0660LEPG06602024-08-26
ENTIMEAG03300NovaLisa Measles Virus IgGMEAG0330MEAG03302024-08-26
ENTIMUMG03400NovaLisa Mumps Virus IgGMUMG0340MUMG03402024-08-26
ENTIPAIG03600NovaLisa Parainfluenza Virus 1, 2, 3 IgGPAIG0360PAIG03602024-08-27
ENTIRSVG03800NovaLisa Respiratory Syncytial Virus IgGRSVG0380RSVG03802024-08-26
ENTISCHG04100NovaLisa Schistosoma mansoni IgGSCHG0410SCHG04102024-08-26
ENTISTRO06900NovaLisa StrongyloidesSTRO0690STRO06902024-08-27
ENTITAEG04200NovaLisa Taenia solium IgGTAEG0420TAEG04202024-08-27
ENTITOCG04500NovaLisa Toxocara canis IgGTOCG0450TOCG04502024-08-27
ENTITRIG04800NovaLisa Trichinella spiralis IgGTRIG0480TRIG04802024-08-27
ENTICOX1G0600NovaLisa Coxiella burnetii (Q-Fever) Phase 1 IgGCOX1G060COX1G06002024-08-26
ENTICOX2G0600NovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgGCOX2G060COX2G06002024-08-26
ENTIPAIG0360NovaLisa Parainfluenza Virus 1, 2, 3 IgGPAIG0360PAIG03602024-08-27
ENTITAEG0420NovaLisa Taenia solium IgGTAEG0420TAEG04202024-08-27
ENTITOCG0450NovaLisa Toxocara canis IgGTOCG0450TOCG04502024-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B379STNG11Strongy DetectTM IgG ELISAINBIOS INTERNATIONAL, INCMDT2024-09-13
ENTISTRO06900NovaLisa StrongyloidesGold Standard Diagnostics Frankfurt GmbHMDT2024-08-27
ENTITRIG04800NovaLisa Trichinella spiralis IgGGold Standard Diagnostics Frankfurt GmbHMDT2024-08-27
ENTITRIG0480NovaLisa Trichinella spiralis IgGGold Standard Diagnostics Frankfurt GmbHMDT2024-08-27
00894175000626AccuDiag ™Diagnostic Automation, Inc.MDT2024-03-06
00894175000831AccuDiag ™Diagnostic Automation, Inc.MDT2024-03-06
04048474058543Ascaris IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMDT2023-09-02
04048474038668Trichinella spiralis IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMDT2023-08-31
04048474042085Strongyloides IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMDT2023-08-31
04048474035216Trichinella spiralis IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMDT2023-08-29
00840239038661Trichinella spiralis IgG ELISADRG International IncMDT2023-08-25
04049016131601Anti-Strongyloides ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMDT2022-12-08
B350GSD0130120Strongyloides IgG ELISA Test KitGold Standard Diagnostics CorporationMDT2022-11-25
B350GSD0130020Trichinella spiralis IgG ELISA Test KitGold Standard Diagnostics CorporationMDT2022-10-14
07640158219256Ascaris IgG ELISABordier affinity products S.A.MDT2022-09-29
07640158219751Trichinella spiralis IgG ELISABordier affinity products S.A.MDT2022-09-28
07640158219454Strongyloides ratti IgG ELISABordier affinity products S.A.MDT2022-08-08
00894175000121AccuDiag ™ Diagnostic Automation, Inc.MDT2021-08-23
00840239035219Trichinella spiralis IgG ELISADRG International IncMDT2021-06-07
00840239042088Strongyloides IgG ELISADRG International IncMDT2021-06-07
00840239058546Ascaris IgG ELISADRG International IncMDT2021-06-07