FDA.reportPublic FDA data

Amazewell

Primary DI
30850065976458
Brand
Amazewell
Company
Guangzhou Decheng Biotechnology Co., LTD
Model
AFD-154
Device description
Amazewell™ Multi-Drug Urine Test Dipcard, 5-Panel, 25T/Box
Published
2024-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PTHTest, Barbiturate, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTHTest, Barbiturate, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240698000Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardGuangzhou Decheng Biotechnology Co., Ltd.2024-05-10DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065976457PrimaryGS10
30850065976458Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065976457008500659764578500659764570850065976457
3085006597645830850065976458

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate 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 opiate and/or opiate 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
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00840050500170OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500460OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11