FDA.reportPublic FDA data

GenaCheck® Early Result Pregnancy Test

Primary DI
00810143620221
Brand
GenaCheck® Early Result Pregnancy Test
Company
Genabio Diagnostics Inc.
Model
N/A
Published
2025-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143620221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143620221008101436202218101436202210810143620221

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin 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 total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, 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 to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
118586095
Device count
1
DM exempt
false
Premarket exempt
false
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
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
00810143620207GenaCheck®PdG At-Home Ovulation Confirmation 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
00050428050460CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428082102CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428087268CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428087589CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428049556CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-02
06938444982801DAVIDEquinox Biotech Co., Ltd.LCX2026-06-01
00049696240482VeriQuickFOURSTAR GROUP INC.LCX2026-04-13
00072036734280Harris TeeterHarris Teeter, LLCLCX2026-02-27
00072036734297Harris TeeterHarris Teeter, LLCLCX2026-02-27
00075450847635Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847666Hy-Vee® Analog Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847673Hy-Vee® Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00195515147545AmazonAMAZON.COM SERVICES LLCLCX2026-02-20
00195515147552AmazonAMAZON.COM SERVICES LLCLCX2026-02-20
00311917083803WalgreensWALGREEN CO.LCX2026-02-17
00311917083957WalgreensWALGREEN CO.LCX2026-02-17
00311917084022WalgreensWALGREEN CO.LCX2026-02-17
00070552251137Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
00311917083452WalgreensWALGREEN CO.LCX2026-02-05
00311917083513WalgreensWALGREEN CO.LCX2026-02-05
00311917083575WalgreensWALGREEN CO.LCX2026-02-05
00045611010000SURESIGN™ Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010017SURESIGN™ Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010024SURESIGN™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010031SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010048SURESIGN™ Ovulation & Pregnancy Rapid TestsGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
10810174471059HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471073HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471097HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471110HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05