FDA.reportPublic FDA data

Analysis Oasis Marijuana (THC) Urine Strip Test

Primary DI
06974246462875
Brand
Analysis Oasis Marijuana (THC) Urine Strip Test
Company
Safecare Biotech (Hangzhou) Co., Ltd.
Model
10 Tests
Catalog number
THC-1011
Published
2026-02-04
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
06974246462875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974246462875069742464628756974246462875

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.

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
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
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
00311917077932WalgreensWALGREEN CO.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
10722066005511Rapid ResponseBTNX IncNFW2026-10-09
10722066018979Rapid ResponseBTNX IncNFW2026-10-08
10722066019013Rapid ResponseBTNX IncNFW2026-10-08
10722066019020Rapid ResponseBTNX IncNFW2026-10-08
10722066019037Rapid ResponseBTNX IncNFW2026-10-08
10722066019044Rapid ResponseBTNX IncNFW2026-10-08
10722066018955Rapid ResponseBTNX IncNFW2026-10-06
10722066018696Rapid ResponseBTNX IncNFW2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-08-14
06936983114011Alltest THC50 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114165Alltest THC50 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114264Alltest THC50 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114448Alltest THC50 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114547Alltest THC50 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114691Alltest THC50 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
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
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
06936983114790Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
06936983114806Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
06936983114813Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
06936983114820Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
06936983114837Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
06936983114844Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16