FDA.reportPublic FDA data

GOODSENSE

Primary DI
00846036009774
Brand
GOODSENSE
Company
GEISS, DESTIN & DUNN, INC
Model
G600977
Device description
GOODSENSE URINARY TRACT INFECTION HOME TEST 3 COUNT
Published
2025-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846036009774PrimaryGS10
00846036309447Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846036009774008460360097748460360097740846036009774
00846036309447008460363094478460363094470846036309447

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
076059836
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846036009453GOODSENSEG6009452025-01-16
00846036209457GOODSENSEG6009452025-01-16
00846036009446GOODSENSEG6009442022-05-03
00846036006438Good Sense69-3522016-09-23
00846036007671Good Sense69-3582016-09-23
00180410000880GoodSense1804100008802020-08-28
00180410000897GoodSense1804100008972020-08-28
00846036009606Good SenseKC009609MPSA1201GSGS2024-02-13
00846036006391Good Sense One Step Pregnancy TestFPPL2016-06-30
00846036009170Good SenseOne Step Pregnancy Test2020-09-21
00846036009187Good SenseOne Step Pregnancy Test2020-09-21
00846036006179Good Sense Early Result Pregnancy TestPLPL2016-06-30
00846036006186Good Sense Early Result Pregnancy TestPLPL2016-06-30
00846036006407Good Sense One Step Pregnancy TestFPPL2016-06-30
00846036002034Good SenseDS00203DS002032022-06-21
10846036002031Good SenseDS00203DS002032022-06-21
00846036000184Good Sense TamponsBGSAS202016-09-20
00846036000337Good Sense TamponsBGSAR082016-09-20
00846036003161Good Sense TamponsBGSGR202016-09-20
00846036004083Good Sense TamponsBGSGS182016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.LJX2026-06-03
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.JMT2026-04-15
16936983186893DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-14
16936983192887Alltest Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192894Alltest Multi-Drug 16 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192900Alltest Multi-Drug 18 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197257Multi-Drug 8 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197264Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197271Multi-Drug 14 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13