FDA.reportPublic FDA data

Equate

Primary DI
00681131107228
Brand
Equate
Company
WAL-MART STORES, INC.
Model
One Step Pregnancy Test
Device description
Walmart (Equate) 5D Cassette
Published
2023-03-16
Public version status
Update
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
K210341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210341000One Step Pregnancy TestSpd Swiss Precision Diagnostics GmbH2022-03-10LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10681131107225PackageGS148In Commercial Distribution
00681131107228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068113110722510681131107225
00681131107228006811311072286811311072280681131107228

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
1-888-287-1915xx@xx.xx

Regulatory Flags#

DUNS number
051957769
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00681131280228EquateWMRT960730V1WMRT960730V12026-11-03
00300656144500Members MarkMembers Mark 2x16oz2026-11-02
06971156891986EquateWH-012026-10-31
00194346099122Equate63040741222026-10-28
00194346726660EquateWAL261012V12026-10-22
00194346210794Equate12026-10-14
00194346726707equate1943467267072026-09-30
00194346726714equate1943467267142026-09-30
08859922800036Equate2.5cm*9.1m2026-09-30
08859922800043Equate2.5cm*3.6m2026-09-30
08859922800050Equate2.5cm*9.1m2026-09-30
08859922800067Equate3.8cm*9.1m2026-09-30
01943461100492EquateUU-012023-09-09
06971156891849Equate4L2026-07-31
069740214114323H Medical69740214114322026-07-31
069740214114943H Medical69740214114942026-07-31
06974021419490EQUATEFRT-022026-07-31
06979191882112Nanacare69791918821122026-07-31
06979191882228Nanacare69791918822282026-07-31
06979191882242Nanacarewhite2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50045611956013ept Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream (Urine)Hangzhou AllTest Biotech Co., Ltd.LCX2026-10-29
50045611956044ept Digital Early Pregnancy Test Midstream(Urine)Hangzhou AllTest Biotech Co., Ltd.LCX2026-10-29
00022600230021First Response™ Daily Check Pregnancy Test KitCHURCH & DWIGHT CO., INC.LCX2026-10-28
00045611956049ept Digital Early Pregnancy Test Midstream(Urine)Hangzhou AllTest Biotech Co., Ltd.LCX2026-10-27
06978151200195HCG One Step Pregnancy Test Midstream OTCHangzhou Aichek Medical Technology Co., Ltd.LCX2026-10-27
00045611951013ept Pregnancy (hCG) Rapid Test Midstream (Urine)Hangzhou AllTest Biotech Co., Ltd.LCX2026-10-26
06978151200201HCG One Step Pregnancy Test Strip OTCHangzhou Aichek Medical Technology Co., Ltd.LCX2026-10-23
10850078377378iHealthiHealth Labs Inc.LCX2026-10-22
00846036009910GoodsenseGEISS, DESTIN & DUNN, INCLCX2026-10-13
00311917090498WalgreensWALGREEN CO.LCX2026-10-12
06923304600193U Pregnancy TestWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-28
86950996041122Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-26
86950996013099Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-25
86950996019039Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-25
06950996006323Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06950996030694Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06950996067577Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06923304600124FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600131FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600155FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600162FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600186FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
00036800028326TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028333TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028340TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028357TopCare HealthTopco Associates, LLCLCX2026-07-13
00810174470543HORMONElife™WONDFO USA CO., LTD.LCX2026-06-26
00633472602603ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHLCX2026-06-25
00050428050460CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428082102CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03