FDA.reportPublic FDA data

Easy@Home KetoneTest Strips (100 test kit)

Primary DI
00855944007239
Brand
Easy@Home KetoneTest Strips (100 test kit)
Company
EASY HEALTHCARE CORPORATION
Model
EZR-101
Catalog number
EZR-101-100
Device description
Easy@Home KetoneTest Strips; Reagent Strips for Urinalysis; Ideal for Keto Diet; 100 ct
Published
2018-07-01
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
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855944007236PackageGS124In Commercial Distribution
00855944007239PrimaryGS10
03085594400720Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085594400723610855944007236
00855944007239008559440072398559440072390855944007239
03085594400720030855944007203085594400720

GMDN Terms#

Term, Definition table
TermDefinition
Ketone (acetoacetate) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of ketone (acetoacetate) in a clinical specimen.

Regulatory Flags#

DUNS number
080278407
Device count
100
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810038637327Easy@Home Marijuana Test Cup(1 test kit)ECTH4-114A3ECTH4-114A3-12026-02-12
00810038638072Easy@Home FSH Urine Test (5 Tests)EFS1-MAEFS1-MA-52025-10-06
00810038638157Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
00810038638850Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
10810038638154Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
10810038638857Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
00810038638874Easy@Home Smart Basal ThermometerEBT-300 PINK2025-07-31
00810038638881Easy@Home Smart Basal ThermometerEBT-300 PURPLE2025-07-31
00810038638898Easy@Home Digital Basal ThermometerEBT-018 PINK2025-07-31
00810038638904Easy@Home Digital Basal ThermometerEBT-018 PURPLE2025-07-31
00810038638928Premom Smart Basal ThermometerEBT-3802025-07-31
00810038638935Easy@Home Digital ThermometerEMT-0262025-07-31
00810038638942Easy@Home Rectal Digital ThermometerEMT-0272025-07-31
00810038638959Easy@Home Digital ThermometerEMT-A122025-07-31
00810038638973Premom Smart Basal ThermometerEBT-3802025-07-31
00810038637150easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
00810038638041easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
10810038637157easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
10810038638048easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
00810038638867Easy@Home Digital Basal ThermometerEBT-100 PURPLE2025-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015091604KetoBMKETOBM USA LLCJIN2026-07-14
00860015091628KetoBMKETOBM USA LLCJIN2026-07-14
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
00816042016417FORAFORA CARE INC.JIN2026-03-20
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
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20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
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00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.JIN2025-10-01
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
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00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-03-31
00816042015199FORAFORA CARE INC.JIN2025-03-14
00850054026729QMedix™Diagnostic Automation, Inc.JIN2024-10-29
00816042015069FORAFORA CARE INC.JIN2024-10-01
00816042015076FORAFORA CARE INC.JIN2024-10-01
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06