FDA.reportPublic FDA data

Amazewell

Primary DI
00850054867841
Brand
Amazewell
Company
Guangzhou Decheng Biotechnology Co., LTD
Model
ASUD-8135H
Device description
Amazewell™ Multi-Drug Urine Test Clicker Cup, 13-Panel
Published
2024-09-29
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
DJGEnzyme Immunoassay, Opiates
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
NGMTest, Phencyclidine (Pcp), Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter
QBFTest, Propoxyphene, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
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
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2
QBFTest, Propoxyphene, 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
00850054867841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054867841008500548678418500548678410850054867841

GMDN Terms#

Term, Definition table
TermDefinition
Cocaine/cocaine 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 cocaine and/or cocaine metabolites 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
554534314
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974464591678One Step® LH Ovulation Rapid Test Dipstick (Urine)40T2026-07-22
06974464591685One Step® LH Ovulation Rapid Test Dipstick (Urine)50T2026-07-22
00850081966005Pregmate50T2026-07-08
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
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
30075450847681Hy-Vee® Ovulation KitIT000418-11/V4072026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFV2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFW2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFY2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NGL2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NGM2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.PTG2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.PTH2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFT2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.PTG2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.PTH2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGM2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGL2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFY2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFW2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFV2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFT2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGG2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20