FDA.reportPublic FDA data

GenaCheck®PdG At-Home Ovulation Confirmation Test

Primary DI
00810143620207
Brand
GenaCheck®PdG At-Home Ovulation Confirmation Test
Company
Genabio Diagnostics Inc.
Model
N/A
Published
2025-01-13
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
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
00810143620207PrimaryGS10
81014362020700Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143620207008101436202078101436202070810143620207
8101436202070081014362020700

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118586095
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143620221GenaCheck® Early Result Pregnancy TestN/A2025-02-26
00810143620115GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E197002025-01-13
00810143620139GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E198002025-01-13
00810143620146GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E199002025-01-13
00810143620153GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E201002025-01-13
00860008954800GenaCheck™ Fentanyl Urine Home-Use Test CassetteRA9-E02525RA9-E025012024-06-14
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TN/A2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TN/A2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TN/A2026-01-21
00810143620344GenaCheck® COVID-19/Flu A&B Rapid Self-TestRA9-E024022025-05-19
00810143620368GenaCheck® COVID-19/Flu A&B Rapid Self-TestRA9-E024042025-05-19
00810143620214GenaCheck® FSH At-Home Menopause TestN/A2025-02-26
00810143620184Genabio COVID-19 Rapid Self-Test KitN/A2025-01-13
00810143620191GenaCheck®LH At-Home Ovulation Prediction TestN/A2025-01-13
00860008954817GenaCheck®Fentanyl Urine Test CassetteN/ARA9-E025252025-01-13
00810143620009GenaCheck Rapid Self-Test Kit For Urinary Tract InfectionsRA9-E018022023-10-06
00810143620047GenaCheck Alcohol Rapid Self-Test KitRA9-E019052023-10-06
00810143620054GenaCheck 5-Drug Rapid Self-Test KitRA9-E021052023-10-06
00810143620061GenaCheck 12-Drug Rapid Self-Test KitRA9-E019022023-10-06
10810143620006GenaCheck Rapid Self-Test Kit For Urinary Tract InfectionsRA9-E018022023-10-06

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
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