FDA.reportPublic FDA data

Strongy DetectTM IgG ELISA

Primary DI
B379STNG11
Brand
Strongy DetectTM IgG ELISA
Company
INBIOS INTERNATIONAL, INC
Model
STNG-1
Published
2024-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
B379STNG11PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004006628
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B379COVGRE1SCoV-2 Detect™ IgG Rapid TestCOVG-RE2022-12-08
B379RCFP251COVID/Flu A&B RespiraDXTM Rapid TestRCFP-25RCFP-252025-10-06
B379RCFPCK101COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (10 sets)RCFP-CK102025-10-06
B379RCFPCK21COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (1 set)RCFP-CK22025-10-06
B379RCFS21COVID/Flu A&B RespiraDXTM Rapid Self-TestRCFS-2RCFS-22025-10-06
B379RCFS41COVID/Flu A&B RespiraDXTM Rapid Self-TestRCFS-4RCFS-42025-10-06
B379COV2E0Smart DetectTM SARS-CoV-2 rRT-PCR KitCOV2-E2020-07-15
B379COVAF201SCoV-2 Ag Detect™ Rapid TestCOVAF-202024-09-13
B379COVAF501SCoV-2 Ag Detect™ Rapid TestCOVAF-502024-09-13
B379ZKM21ZIKV Detect™ 2.0 IgM Capture ELISAIVD2019-05-24
B379COVNE1SCoV-2 Detect™ Neutralizing Ab ELISACOVN-E2022-12-08
B379C19S21COVID-19 Detect™ Rapid Self -TestC19S-22026-01-16
B379RCFPCK201COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (20 sets)RCFP-CK202025-10-06
B379AAP11Active Anthrax Detect Plus Rapid TestAAP-12023-03-03
B379CAGS21SCoV-2 Ag Detect™ Rapid Self-TestCAGS-22022-12-08
B379COVAGRC1SCoV-2 Ag Detect™ Rapid TestCOVAG-RC2022-12-08
B379COVEG1SCoV-2 Detect™ IgG ELISACOVE-G2022-12-08
B379COVEM1SCoV-2 Detect™ IgM ELISACOVE-M2022-12-08
B379CL0251CL Detect Rapid Test for Cutaneous LeishmaniasisCL025CL0252018-09-24
B379CP0501Chagas Detect™ Plus Rapid TestCP050CP0502018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTISTRO06900NovaLisa StrongyloidesGold Standard Diagnostics Frankfurt GmbHMDT2024-08-27
ENTITRIG04800NovaLisa Trichinella spiralis IgGGold Standard Diagnostics Frankfurt GmbHMDT2024-08-27
ENTISTRO0690NovaLisa StrongyloidesGold 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