FDA.reportPublic FDA data

AllSource

Primary DI
00850054867629
Brand
AllSource
Company
Guangzhou Decheng Biotechnology Co., LTD
Model
ALLDTHR
Device description
AllSource DRUG DETECTOR, Single-Panel (THC 50), 25T/Box
Published
2024-09-30
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
K232659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232659000Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupGuangzhou Decheng Biotechnology Co., Ltd.2023-12-13DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054867629PrimaryGS10
30850054867620Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054867629008500548676298500548676290850054867629
3085005486762030850054867620

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
554534314
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974464591654One Step® LH Ovulation Rapid Test Dipstick (Urine)45T2026-07-15
06974464591678One Step® LH Ovulation Rapid Test Dipstick (Urine)40T2026-07-22
06974464591685One Step® LH Ovulation Rapid Test Dipstick (Urine)50T2026-07-22
06974464591272One Step® Progesterone (PdG) Urine Test Strip6T2026-03-31
06974464591296One Step® LH Ovulation Rapid Test Dipstick (Urine)20T2026-03-31
06974464591302One Step® LH Ovulation Rapid Test Dipstick (Urine)30T2026-03-31
06974464591319One Step® LH Ovulation Rapid Test Dipstick (Urine)60T2026-03-31
00850081966005Pregmate50T2026-07-08
06974464591333One Step® HCG Early Rapid Pregnancy Midstream Test5T2026-03-31
06974464591340One Step® HCG Early Rapid Pregnancy Strips15T2026-03-31
06974464591357One Step® 7-PANEL MULTI DRUG URINE TEST5T2026-03-31
00075450847635Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-3/V4072026-02-20
00075450847666Hy-Vee® Analog Pregnancy Rapid TestIT000416-2/V4072026-02-20
00075450847673Hy-Vee® Digital Pregnancy Rapid TestIT000417-2/V4072026-02-20
00075450847680Hy-Vee® Ovulation KitIT000418-11/V4072026-02-20
30075450847636Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-3/V4072026-02-20
00075450847642Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-2/V4072026-02-20
00075450847659Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-1/V4072026-02-20
30075450847667Hy-Vee® Analog Pregnancy Rapid TestIT000416-2/V4072026-02-20
30075450847674Hy-Vee® Digital Pregnancy Rapid TestIT000417-2/V4072026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-08-14
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11