FDA.reportPublic FDA data

HYSEN Fentanyl Rapid Test

Primary DI
10850076289031
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
136301242
Device count
40
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
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
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00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
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00840050500262OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
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00840050500361OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
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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