FDA.reportPublic FDA data

UP & UP

Primary DI
00751774000016
Brand
UP & UP
Company
TARGET CORPORATION
Model
Six Days Sooner Pregnancy Test
Catalog number
N/A
Device description
Target TPS 6 Day Pink
Published
2025-12-17
Public version status
New
Distribution status
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
K213379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213379000Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH2022-09-21LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10751774000013PackageGS124In Commercial Distribution
00751774000016PrimaryGS10
00633472000690Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075177400001310751774000013
00751774000016007517740000167517740000160751774000016
00633472000690006334720006906334720006900633472000690

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

Contacts#

Phone, Email table
PhoneEmail
1-800-899-7353xx@xx.xx

Regulatory Flags#

DUNS number
006961700
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017276229370Up&Up2450706862020-01-24
00095072096006Up&Up 245-09-78819SMPP1002TG2026-04-22
00017276226171Up&Up2450701462020-02-28
00017276226188Up&Up2450702042020-02-28
00017276226218Up&Up2450704082020-02-28
00017276226270Up&Up2450710342020-02-28
00017276229363Up&Up2450706792020-01-24
00017276231625Up&Up2450706522020-03-30
00017276233094Up&Up2450705762020-02-28
00017276238655Up&Up2450778132022-02-14
00017276239614up&up2450749432024-02-05
00751774733532Up & Up Advanced Early Result Pregnancy Test2020-09-21
00751774733631Up & Up Advanced Early Result Pregnancy Test2020-09-28
06941937216819Up & Up245-07-02932022-07-12
00310119304242up & up multipurpose solution630424FCP-41222026-01-09
06945397906228Up&Up245-07-07092024-03-01
06945397906242Up&Up245-07-05902024-03-01
06945397906266Up&Up245-07-05952024-03-01
06945397906204Up&Up245-07-07072024-03-01
06945397902442Up&Up245-07-01042021-01-07

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