FDA.reportPublic FDA data

One Step® 7-PANEL MULTI DRUG URINE TEST

Primary DI
06974464591357
Brand
One Step® 7-PANEL MULTI DRUG URINE TEST
Company
Guangzhou Decheng Biotechnology Co., LTD
Model
5T
Device description
Multi drug 7 panel test pack of 5
Published
2026-03-31
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
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974464591357PrimaryGS10
36974464591358Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974464591357069744645913576974464591357
3697446459135836974464591358

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine-specific 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 a specific amphetamine 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
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06974464591333One Step® HCG Early Rapid Pregnancy Midstream Test5T2026-03-31
06974464591340One Step® HCG Early Rapid Pregnancy Strips15T2026-03-31
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
30075450847681Hy-Vee® Ovulation KitIT000418-11/V4072026-02-20
00045611010000SURESIGN™ Pregnancy Rapid Test01000-02026-01-28
00045611010017SURESIGN™ Early Detection Pregnancy Test01001-72026-01-28
00045611010024SURESIGN™ Digital Pregnancy Rapid Test01002-42026-01-28
00045611010031SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid Test01003-12026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066015053Rapid ResponseBTNX IncNFW2026-05-15
10722066015053Rapid ResponseBTNX IncNFY2026-05-15
10722066015053Rapid ResponseBTNX IncNFV2026-05-15
10722066015053Rapid ResponseBTNX IncNGG2026-05-15
10722066015053Rapid ResponseBTNX IncNGL2026-05-15
10722066015084Rapid ResponseBTNX IncNGL2026-05-15
10722066015084Rapid ResponseBTNX IncNFW2026-05-15
10722066015084Rapid ResponseBTNX IncNFY2026-05-15
10722066015084Rapid ResponseBTNX IncNGG2026-05-15
10722066015084Rapid ResponseBTNX IncNFV2026-05-15
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
10197344170203MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-29
10197344170210MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-23
10722066011260Rapid ResponseBTNX IncNFW2026-01-19
10722066011260Rapid ResponseBTNX IncNFV2026-01-19
10722066011260Rapid ResponseBTNX IncNGG2026-01-19
10722066011260Rapid ResponseBTNX IncNFY2026-01-19
10722066011260Rapid ResponseBTNX IncNGL2026-01-19
10722066011277Rapid ResponseBTNX IncNFW2026-01-19
10722066011277Rapid ResponseBTNX IncNFV2026-01-19
10722066011277Rapid ResponseBTNX IncNGG2026-01-19
10722066011277Rapid ResponseBTNX IncNGL2026-01-19
10722066011277Rapid ResponseBTNX IncNFY2026-01-19
10722066009083Rapid ResponseBTNX IncNFY2025-10-03
10722066009083Rapid ResponseBTNX IncNGL2025-10-03
10722066009083Rapid ResponseBTNX IncNGG2025-10-03
10722066009083Rapid ResponseBTNX IncNFW2025-10-03
10722066009083Rapid ResponseBTNX IncNFV2025-10-03
10722066010973Rapid ResponseBTNX IncNFY2025-07-08