FDA.reportPublic FDA data

HYSEN Multi-Panel Drug Test Dip Card

Primary DI
00850076289027
Brand
HYSEN Multi-Panel Drug Test Dip Card
Company
HYSEN INC.
Model
HDOA-1124A
Catalog number
HDOA-1124A
Device description
HYSEN Multi-Panel Drug Test Dip Card, PCP /25, AMP/1000, BAR/300, BUP/10, BZO/300, COC/300, MDMA/500, MET/1000, MTD/300, OPI/300, OXY/100, THC/50
Published
2025-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
NGMTest, Phencyclidine (Pcp), Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, 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
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170049000AssureTech Panel Dip Test, AssureTech Quick Cup TestAssure Tech. (Hangzhou) Co, Ltd.2017-05-02NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850076289024PackageGS120In Commercial Distribution
00850076289027PrimaryGS10
20850076289021Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007628902410850076289024
00850076289027008500762890278500762890270850076289027
2085007628902120850076289021

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 multiple drugs of abuse 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
136301242
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850076289055Hysen Drug Test CupsHDRC-187-011HDRC-187-0112026-03-18
10850076289062Hysen Drug Test CupsHDRC-1147-011HDRC-1147-0112026-03-18
10850076289079Hysen Drug Test CardsHDOA-154-021HDOA-154-0212026-03-18
00850076289034HYSEN Fentanyl Rapid TestHFYL-102AHFYL-102A2025-08-28
00850076289041HYSEN Multiple Drugs Test CupHDOA-1177AHDOA-1177A2025-08-28
10850076289024HYSEN Multi-Panel Drug Test Dip CardHDOA-1124AHDOA-1124A2025-08-28
10850076289031HYSEN Fentanyl Rapid TestHFYL-102AHFYL-102A2025-08-28
10850076289048HYSEN Multiple Drugs Test CupHDOA-1177AHDOA-1177A2025-08-28
10850076289000Hysen Drug Test CupsHYD1141-011HYD1141-0112025-08-04
10850076289017Hysen Drug Test CardsHYD1122-011HYD1122-0112025-08-04
00850076289003Hysen Drug Test CupsHYD1141-011HYD1141-0112025-08-04
00850076289010Hysen Drug Test CardsHYD1122-011HYD1122-0112025-08-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10722066018009Rapid ResponseBTNX IncNGG2026-07-14
10722066018009Rapid ResponseBTNX IncNFY2026-07-14
10722066018009Rapid ResponseBTNX IncNFW2026-07-14
10722066018009Rapid ResponseBTNX IncNFV2026-07-14
10722066018009Rapid ResponseBTNX IncPTH2026-07-14
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFW2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGM2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGG2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGL2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFY2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFT2026-07-09
00810174471229Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NFT2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGG2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFV2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFT2026-06-26
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
10197344170203MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-29
10197344170210MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-23
10722066009083Rapid ResponseBTNX IncPTH2025-10-03
10722066009083Rapid ResponseBTNX IncPTG2025-10-03
10722066009083Rapid ResponseBTNX IncNGM2025-10-03