FDA.report

Easy@Home KetoneTest Strips (100 test kit)

Primary DI
10855944007236
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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications

CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10855944007236PackageGS124In Commercial Distribution
00855944007239PrimaryGS10
03085594400720Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085594400723610855944007236
00855944007239008559440072398559440072390855944007239
03085594400720030855944007203085594400720

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080278407
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
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
10810038637157easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
10810038638048easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
10810038638864Easy@Home Digital Basal ThermometerEBT-100 PURPLE2025-07-17
00810038638911Easy@Home Dual Digital ThermometerEBT-0132025-07-17
00810038633992Easy@Home Dual Digital ThermometerEBT-0132023-01-30
10810038638093Easy@Home Marijuana Test Strip(THC 20)ESTH-215ESTH-215-52025-07-10
00810038637365easy@Home TENS AND MUSCLE STIMULATOREHE0802025-04-17
10810038636846Easy@Home Pregnancy Test (5 tests) EZW1-MDEZW1-MD-52024-11-08
10810038636266Easy@Home Blood Pressure Monitor EBP-095 BlackEBP-0952024-11-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860015091642KetoBMKETOBM USA LLCJIN2026-01-19
00199284689879SureMediks B-Ketone Test Strips (25pcs/box)Rasimo Systems LLCJIN2025-12-05
80816042015195FORAFORA CARE INC.JIN2025-03-14
80816042015065FORAFORA CARE INC.JIN2024-10-01
80816042015072FORAFORA CARE INC.JIN2024-10-01
80816042015188FORAFORA CARE INC.JIN2024-04-19
80816042014044FORAFORA CARE INC.JIN2023-07-07
00613647025253FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JIN2023-06-20
20613647025264FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JIN2023-06-20
00850017460089BIOCOACH Blood Ketone Test Strips 50 Pack (Foil)AMVENTUREX, INC.JIN2023-05-31
16976122480000LYZChangchun Lyz Technology Co., Ltd.JIN2023-03-28
00860009154001K-CHECKBiorex Labs LLCJIN2022-12-02
00860001641752KetoBMKetobm LLCJIN2022-11-21
00860182000645KetoBMKetobm LLCJIN2022-11-21
08806141301592QTEST KDFI CO.,LTDJIN2022-10-14
00860005745913bkt ß-Ketone Test Strips (50 pcs/box)Adam LawrenceJIN2022-10-13
08806141302650One+Step KetoneDFI CO.,LTDJIN2022-10-03
06971404131581Blood Ketone Control solution(level 1)e-Linkcare Meditech Co., LtdJIN2022-05-17
06971404131598Blood Ketone Control solution(level 2)e-Linkcare Meditech Co., LtdJIN2022-05-17
06971404131604Blood Ketone Control solution(level 3)e-Linkcare Meditech Co., LtdJIN2022-05-17
80884389181972MedlineMEDLINE INDUSTRIES, INC.JIN2022-04-13
00810038631431Easy@Home Ketone Test Strips (20 Pack)EASY HEALTHCARE CORPORATIONJIN2022-02-17
00810038632445Easy@Home Ketone Test Strips (50 Pack)EASY HEALTHCARE CORPORATIONJIN2022-02-17
00850017460034BIOCOACH Blood Glucose and Ketone Monitoring SystemAMVENTUREX, INC.JIN2021-12-28
16971404130918Blood Ketone Monitoring Systeme-Linkcare Meditech Co., LtdJIN2021-12-17
26971404131196Blood Ketone Test Stripse-Linkcare Meditech Co., LtdJIN2021-12-17
10885325000853KetoSensi-SENS, Inc.JIN2020-11-10
10885325001492KetoSensi-SENS, Inc.JIN2020-11-10
00311917173900TRUEplusTRIVIDIA HEALTH, INC.JIN2020-10-21
00850001462334GOJJI BLOOD KETONE TEST STRIPGOJJI, INC.JIN2020-04-08