FDA.reportPublic FDA data

T Testahead HCG Urine Test Strip

Primary DI
06974246462578
Brand
T Testahead HCG Urine Test Strip
Company
Safecare Biotech (Hangzhou) Co., Ltd.
Model
50 Tests
Catalog number
HCG-1011
Published
2025-08-20
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200133000hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamSafecare Biotech (Hangzhou) Co., Ltd.2020-08-13LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974246462578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974246462578069742464625786974246462578

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544349634
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974246462905Safecare Vaginal PH Rapid Test Cassette3 TestsPH-60122026-03-18
06974246462936Exploro Urinary Tract Infection (UTI) Test15 testsUTI-12026-03-09
06974246462943Exploro Urinary Tract Infection (UTI) Test10 testsUTI-12026-03-09
06974246462950Exploro Urinary Tract Infection (UTI) Test7 testsUTI-12026-03-09
06974246462967Exploro Urinary Tract Infection (UTI) Test5 testsUTI-12026-03-09
06974246462974Exploro Urinary Tract Infection (UTI) Test4 testsUTI-12026-03-09
06974246462981Exploro Urinary Tract Infection (UTI) Test3 testsUTI-12026-03-09
06974246462851Analysis Oasis Marijuana (THC) Urine Strip Test25 TestsTHC-10112026-02-04
06974246462868Analysis Oasis Marijuana (THC) Urine Strip Test15 TestsTHC-10112026-02-04
06974246462875Analysis Oasis Marijuana (THC) Urine Strip Test10 TestsTHC-10112026-02-04
06974246462882Analysis Oasis Marijuana (THC) Urine Strip Test5 TestsTHC-10112026-02-04
06974246462899Analysis Oasis Marijuana (THC) Urine Strip Test3 TestsTHC-10112026-02-04
06974246462813Deteta THC Urine Test15 TestsD.1012025-11-05
06974246462820Deteta THC Urine Test10 TestsD.1012025-11-05
06974246462837Deteta THC Urine Test5 TestsD.1012025-11-05
06974246462424Exploro Highly Sensitive Urine Drug Test (14-Panel)10 testsMULTID14-12025-07-30
06974246462431Exploro Highly Sensitive Urine Drug Test (14-Panel)5 testsMULTID14-12025-07-30
06974246462448Exploro Highly Sensitive Urine Drug Test (14-Panel)4 testsMULTID14-12025-07-30
06974246462455Exploro Highly Sensitive Urine Drug Test (14-Panel)3 testsMULTID14-12025-07-30
06974246462462Exploro Highly Sensitive Urine Drug Test (14-Panel)2 testsMULTID14-12025-07-30

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