FDA.reportPublic FDA data

HYSEN Multiple Drugs Test Cup

Primary DI
10850076289048
Brand
HYSEN Multiple Drugs Test Cup
Company
HYSEN INC.
Model
HDOA-1177A
Catalog number
HDOA-1177A
Device description
HYSEN Multiple Drugs Test Cup, AMP/500, BAR/300, BUP/10, BZO/300, COC/150, EDDP/300, FEN/1, MDMA/500, MET/500, MOR/300, NFYL/5, MTD/300, OXY/100, PCP/25, PPX/300, TCA/1000, THC/50
Published
2025-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K243996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243996000AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test CupAssure Tech., LLC2025-02-07NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850076289048PackageGS14In Commercial Distribution
00850076289041PrimaryGS10
20850076289045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007628904810850076289048
00850076289041008500762890418500762890410850076289041
2085007628904520850076289045

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.

Sterilization Methods#

Method table
Method

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
false
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
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
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