FDA.reportPublic FDA data

NovaLisa Leptospira IgG

Primary DI
ENTILEPG06600
Brand
NovaLisa Leptospira IgG
Company
Gold Standard Diagnostics Frankfurt GmbH
Model
LEPG0660
Catalog number
LEPG0660
Device description
The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human serum or plasma (heparin).
Published
2024-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GRYAntigens, All, Leptospira Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRYAntigens, All, Leptospira Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENTILEPG06600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Leptospira species 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 one or multiple species of Leptospira bacteria 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
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
ENTISTRO0690NovaLisa StrongyloidesSTRO0690STRO06902024-08-27
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
ENTILEPG0660NovaLisa Leptospira IgGGold Standard Diagnostics Frankfurt GmbHGRY2024-08-26
00850049545211AccuDiag ™Diagnostic Automation, Inc.GRY2024-03-06
04048474042450Leptospira IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungGRY2023-08-31
00840239057518Leptospira IgG ELISA DRG International IncGRY2023-08-25
04048474057515Leptopspira IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRY2019-06-10
00404847457513Leptopspira IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRY2019-06-10
00840239042453Leptopspira IgG ELISADRG International IncGRY2019-06-05
00613745000046ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00613745000152ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00613745000169ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00813545026318Leptospira IgG Antibody 96 Test SCIMEDX CORPORATIONGRY2016-09-21