FDA.reportPublic FDA data

Topcare One Step Pregnancy Test

Primary DI
00036800339774
Brand
Topcare One Step Pregnancy Test
Company
Topco Associates, LLC
Model
FPPL
Device description
FPPL Topcare TPS +/-
Published
2016-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042280000FACT PLUS ONE-STEP PREGNANCY TEST KITUnipath , Ltd.2004-09-10LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00036800377653PackageGS124Not in Commercial Distribution
00036800339774PrimaryGS10
00633472000133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00036800377653000368003776530368003776530036800377653
00036800339774000368003397740368003397740036800339774
00633472000133006334720001336334720001330633472000133

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
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-423-0139topcare@topco.com
800-899-7353topcare@topco.com

Regulatory Flags#

DUNS number
072943876
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00036800216587TopCare health0368002165872019-07-31
00036800216600TopCare health0368002166002019-07-31
00036800413634TopCare health0368004136342019-10-31
00036800024892TopCare health0368000248922026-02-05
10036800024899TopCare health0368000248922026-02-05
00036800024908TopCare health0368000249082026-01-30
10036800024905TopCare health0368000249082026-01-30
00036800022683TopCare HealthTOP4045V2TOP4045V22026-01-27
80368000226834TopCare HealthTOP4045V2TOP4045V22026-01-27
20036800367436TopCare Premium Blood Glucose Meter8000-071642016-09-24
00036800250789TopCare Insulin Syringe1029122016-10-04
00036800250826TopCare Insulin Syringe0331082016-09-24
20036800367443TopCare Premium Blood Glucose Test Strips8000-071582016-09-24
20036800422159TopCare Premium Blood Glucose Test Strips8000-104432016-09-24
00036800250796TopCare Insulin Syringe0330082016-09-24
00036800250802TopCare Insulin Syringe0530082016-09-24
00036800250833TopCare Insulin Syringe0531082016-09-24
00036800250840TopCare Insulin Syringe1031082016-09-24
00036800250765TopCare Insulin Syringe0329122016-09-24
00036800250772TopCare Insulin Syringe0529122016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00197870203805H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-28
00197870203812H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-28
00197870203843H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-12
00197870203836H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-11
00311917077550WalgreensWALGREEN CO.LCX2025-10-10
00311917077567WalgreensWALGREEN CO.LCX2025-10-10