FDA.reportPublic FDA data

Wondfo

Primary DI
10816862024088
Brand
Wondfo
Company
WONDFO USA CO., LTD.
Model
DW199-S-5BX-A
Device description
5-Strip; PDG Progesterone test
Published
2024-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10816862024088PackageGS1200In Commercial Distribution
00816862024081PrimaryGS10
00816862024098Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202408810816862024088
00816862024081008168620240818168620240810816862024081
00816862024098008168620240988168620240980816862024098

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
5
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
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
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