FDA.reportPublic FDA data

HYSEN Fentanyl Rapid Test

Primary DI
00850076289034
Brand
HYSEN Fentanyl Rapid Test
Company
HYSEN INC.
Model
HFYL-102A
Catalog number
HFYL-102A
Device description
HYSEN Fentanyl Rapid Test, 1 ng/mL
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
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGLTest, Opiates, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240351000FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)Assure Tech., LLC2024-03-06NGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850076289031PackageGS125In Commercial Distribution
00850076289034PrimaryGS10
20850076289038Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007628903110850076289031
00850076289034008500762890348500762890340850076289034
2085007628903820850076289038

GMDN Terms#

Term, Definition table
TermDefinition
Fentanyl 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 fentanyl 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
40
Lot or batch
true
Expiration date on label
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
10850076289079Hysen Drug Test CardsHDOA-154-021HDOA-154-0212026-03-18
00850076289027HYSEN Multi-Panel Drug Test Dip CardHDOA-1124AHDOA-1124A2025-08-28
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
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500460OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11