FDA.reportPublic FDA data

Hysen Drug Test Cups

Primary DI
10850076289086
Brand
Hysen Drug Test Cups
Company
HYSEN INC.
Model
HDRC-1127-011
Catalog number
HDRC-1127-011
Device description
Hysen Drug Test Cups PCP25/AMP1000/BAR300/BUP10/BZO300/COC300/MET1000/MDMA500/THC50/MOP300/MTD300/OXY100
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850076289083PackageGS18In Commercial Distribution
10850076289086PrimaryGS10
00850076289089Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085007628908320850076289083
1085007628908610850076289086
00850076289089008500762890898500762890890850076289089

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
136301242
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
true
Sterilization required before use
false

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
10850076289079Hysen Drug Test CardsHDOA-154-021HDOA-154-0212026-03-18
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
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCLCM2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDIS2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDJG2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCJXM2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDIO2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDJR2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDJC2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-11-04
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDIO2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJC2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJR2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCJXM2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDKZ2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDIS2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLCM2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLDJ2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJG2026-10-30
B115SCDCARD01THC501SnapCheckDx Multi-Drug Screen Test DipcardADVIN BIOTECH, INC.LDJ2026-10-30
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.DIO2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LCM2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28