FDA.reportPublic FDA data

easy@Home PdG Urine Test Strip

Primary DI
00810038638041
Brand
easy@Home PdG Urine Test Strip
Company
EASY HEALTHCARE CORPORATION
Model
EZW3-S
Catalog number
EZW3-S-10
Device description
easy@Home PdG Urine Test Strip (10 tests)
Published
2025-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKEImmunoassay, Pregnanediol Glucuronide, Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810038638048PackageGS1150In Commercial Distribution
00810038638041PrimaryGS10
30810038638042Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081003863804810810038638048
00810038638041008100386380418100386380410810038638041
3081003863804230810038638042

GMDN Terms#

Term, Definition table
TermDefinition
Natural conception assistance kitA collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use.

Regulatory Flags#

DUNS number
080278407
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
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
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
10810038638864Easy@Home Digital Basal ThermometerEBT-100 PURPLE2025-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974464591272One Step® Progesterone (PdG) Urine Test StripGuangzhou Decheng Biotechnology Co., LTDQKE2026-03-31
00850035206393ProovMfb Fertility, Inc.QKE2025-08-15
00810038637150easy@Home PdG Urine Test StripEASY HEALTHCARE CORPORATIONQKE2025-07-24
10810038637157easy@Home PdG Urine Test StripEASY HEALTHCARE CORPORATIONQKE2025-07-24
10810038638048easy@Home PdG Urine Test StripEASY HEALTHCARE CORPORATIONQKE2025-07-24
00810174470505HORMONElife™WONDFO USA CO., LTD.QKE2025-07-04
00816862027266HORMONElife™WONDFO USA CO., LTD.QKE2025-07-03
10816862027263HORMONElife™WONDFO USA CO., LTD.QKE2025-07-03
00990312537984 Eli Progesterone Hormometer™Eli Science IncQKE2025-05-05
00810143620207GenaCheck®PdG At-Home Ovulation Confirmation TestGenabio Diagnostics Inc.QKE2025-01-13
00816862024081WondfoWONDFO USA CO., LTD.QKE2024-12-31
10816862024088WondfoWONDFO USA CO., LTD.QKE2024-12-31
00816862026436WondfoWONDFO USA CO., LTD.QKE2024-12-24
10816862026433WondfoWONDFO USA CO., LTD.QKE2024-12-24
00850054867469AmazewellGuangzhou Decheng Biotechnology Co., LTDQKE2024-09-30
00850054867544AmazewellGuangzhou Decheng Biotechnology Co., LTDQKE2024-09-30
30850054867460AmazewellGuangzhou Decheng Biotechnology Co., LTDQKE2024-09-30
30850054867545AmazewellGuangzhou Decheng Biotechnology Co., LTDQKE2024-09-30
00850035206157ProovMfb Fertility, Inc.QKE2023-05-17
00850035206164ProovMfb Fertility, Inc.QKE2023-05-17
00850035206065ProovMfb Fertility, Inc.QKE2023-04-20
00850035206126ProovMfb Fertility, Inc.QKE2023-03-28
00860002790817ProovMfb Fertility, Inc.QKE2023-03-24