FDA.reportPublic FDA data

HORMONElife™

Primary DI
10816862027263
Brand
HORMONElife™
Company
WONDFO USA CO., LTD.
Model
W199-S-6BX
Device description
HORMONElife™ PdG Urine Test Strip OTC 6PK
Published
2025-07-03
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

Contact Domains#

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
10816862027263PackageGS1160In Commercial Distribution
00816862027266PrimaryGS10
00816862027259Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202726310816862027263
00816862027266008168620272668168620272660816862027266
00816862027259008168620272598168620272590816862027259

GMDN Terms#

Term, Definition table
TermDefinition
Multiple female fertility marker IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of a combination of different types of female fertility markers [e.g., estrone-3-glucuronide (E1-3G), pregnanediol-3-glucuronide (PdG), luteinizing hormone (LH) and follicle stimulating hormone (FSH)] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
630-468-2199wondfo@wondfousa.com

Regulatory Flags#

DUNS number
849098897
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816862027303WELLlife™WCOV-CON-52026-06-01
00816862028416WELLlife™WCOVID-POC-252026-06-01
00816862028294SAFElife™CDOA-L11135A32026-05-15
00816862028324WELLlife™ WFOB-OTC-2BX2026-05-15
00816862028348SAFElife™CDOA-6135F2026-05-15
00816862028362SAFElife™TDOA-6135F2026-05-15
00816862028393SAFElife™WEDDP-1142026-05-15
00816862028249SAFElife™CDOA-12135NT2026-01-15
00816862028270HORMONElife™H1-S-20BG2026-01-15
00816862027723HORMONElife™H1-S-E10-25BX-CLIA2026-01-15
00816862028164SAFElife™CDOA-12135NT2026-01-15
00816862028263HORMONElife™H1-S-20BG2026-01-15
00816862028027SAFElife™CDOA-L111452025-12-15
00816862028089SAFElife™CDOA-L11135A32025-12-15
00816862028102HORMONElife™H2-S-50BG2025-12-15
00816862028157HORMONElife™H1-C-25BX-CLIA2025-12-15
00816862028010SAFElife™CDOA-L111452025-12-15
00816862028072SAFElife™CDOA-L11135A32025-12-15
00816862028096HORMONElife™H2-S-50BG2025-12-15
00816862028119HORMONElife™H1-C-25BX-CLIA2025-12-15

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
00810038638041easy@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
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