FDA.reportPublic FDA data

Hysen Drug Test Cards

Primary DI
10850076289079
Brand
Hysen Drug Test Cards
Company
HYSEN INC.
Model
HDOA-154-021
Catalog number
HDOA-154-021
Device description
Hysen Drug Test CardsCOC300/MET1000/OPI2000/PCP25/THC50
Published
2026-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850076289076PackageGS140In Commercial Distribution
10850076289079PrimaryGS10
00850076289072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085007628907620850076289076
1085007628907910850076289079
00850076289072008500762890728500762890720850076289072

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
136301242
Device count
25
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850076289706HYSEN Multiple Drugs Test CupHDOA-1127-011HDOA-1127-0112026-07-20
00850076289713HYSEN Multiple Drugs Test CupHDOA-1147-011HDOA-1147-0112026-07-20
10850076289055Hysen Drug Test CupsHDRC-187-011HDRC-187-0112026-03-18
10850076289062Hysen Drug Test CupsHDRC-1147-011HDRC-1147-0112026-03-18
00850076289027HYSEN Multi-Panel Drug Test Dip CardHDOA-1124AHDOA-1124A2025-08-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.LCM2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.LCM2026-10-14
06942598249376One Step® Fentanyl(FYL1) Urine Test PanelHangzhou AllTest Biotech Co., Ltd.DJG2026-10-12
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LCM2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DJG2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LCM2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DIO2026-09-24
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LCM2026-08-01