FDA.reportPublic FDA data

GoldN Easy to Use Pregnancy Test

Primary DI
00850059915639
Brand
GoldN Easy to Use Pregnancy Test
Company
NOVODX Corporation
Model
GN040ST02-US
Catalog number
GN040ST
Device description
The GoldNTM Easy to Use Pregnancy Test is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The GoldNTM Easy to Use Pregnancy Test is designed for self-testing use.
Published
2025-01-07
Public version status
Update
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
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
00850059915639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059915639008500599156398500599156390850059915639

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119046376
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850059915370GoldN Easy to Use FSH TestGN011ST02-USGN011ST2025-01-24
00850059915882GoldN Easy to Use Vaginal pH TestGN041ST01-USGN041ST2025-01-10
00850059915646GoldN Easy to Use Ovulation TestGN013ST10-USGN013ST2024-02-22
00850059915424GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC)GN013STGN013ST25-US2024-02-23

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