FDA.reportPublic FDA data

Amazon

Primary DI
00195515045902
Brand
Amazon
Company
AMAZON.COM SERVICES LLC
Model
Early Result Pregnancy Test
Device description
Amazon Basic Care TPS ER
Published
2025-05-20
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
10195515045909PackageGS124Not in Commercial Distribution
00195515045902PrimaryGS10
00633472000126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019551504590910195515045909
00195515045902001955150459021955150459020195515045902
00633472000126006334720001266334720001260633472000126

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
128990418
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195515153287Amazon Basics6304336304332026-08-07
00195515153294Amazon Basics6304336304332026-08-07
00195515147552Amazon20002241N/A2026-02-20
00195515147545Amazon20002240N/A2026-02-20
00195515050098AmazonDigital Pregnancy TestN/A2025-05-20
00195515017947Amazon BasicsB098VHYX2MB098VHYX2M2021-10-27
10195515045909AmazonEarly Result Pregnancy Test2025-05-20
10195515050095AmazonDigital Pregnancy TestN/A2025-05-20
00195515045247Amazon BasicsSQN542025-01-25
10195515045244Amazon BasicsSQN542025-01-25
00195515047944Amazon Basic Care B09S3W7SW72023-12-21
00195515047098ABC1955150470982024-06-25
00195515047104ABC1955150471042024-06-25
10195515047095ABC1955150470982024-06-25
10195515047101ABC1955150471042024-06-25
00195515047951Amazon Basic Care B09S3VLQLL2023-12-21
00195515047968Amazon Basic CareB095S3WFGQB2023-12-21
10195515047958Amazon Basic Care B09S3VLQLL2023-12-21
10195515047965Amazon Basic CareB095S3WFGQB2023-12-21
00195515043182Amazon Basic Care B0CJ9T9GKY2023-12-12

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