FDA.reportPublic FDA data

Deteta THC Urine Test

Primary DI
06974246462820
Brand
Deteta THC Urine Test
Company
Safecare Biotech (Hangzhou) Co., Ltd.
Model
10 Tests
Catalog number
D.101
Published
2025-11-05
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
NFWTest, Cannabinoid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191924000SAFECARE® THC Urine Strip TestSafecare Biotech (Hangzhou) Co., Ltd.2019-08-16NFW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974246462820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974246462820069742464628206974246462820

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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. It is not intended to be used for self-testing.

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
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
06974246462479Exploro Highly Sensitive Urine Drug Test (14-Panel)1 testMULTID14-12025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066015053Rapid ResponseBTNX IncNFW2026-05-15
10722066015084Rapid ResponseBTNX IncNFW2026-05-15
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131671Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131695Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983144770Discover Multi-Drug 9 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983148846Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine) Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983169599Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983169865Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983169872Discover Multi-Drug 8 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983170007Alltest Multi-Drug 12 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983170014Alltest Multi-Drug 13 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983170021Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983170038Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983171998Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983172025Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983172414Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-14
16936983172421Alltest Multi-Drug 12 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-14
16936983179642Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-14