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 |
|---|---|
| NGL | Test, Opiates, Over The Counter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K240351 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10850076289031 | Package | GS1 | 25 | In Commercial Distribution |
| 00850076289034 | Primary | GS1 | 0 | |
| 20850076289038 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10850076289031 | 10850076289031 | ||
| 00850076289034 | 00850076289034 | 850076289034 | 0850076289034 |
| 20850076289038 | 20850076289038 |
GMDN Terms#
| Term | Definition |
|---|---|
| Fentanyl IVD, kit, rapid ICT, clinical | A 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 |
|---|
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 | Catalog | Published |
|---|---|---|---|---|
| 10850076289055 | Hysen Drug Test Cups | HDRC-187-011 | HDRC-187-011 | 2026-03-18 |
| 10850076289062 | Hysen Drug Test Cups | HDRC-1147-011 | HDRC-1147-011 | 2026-03-18 |
| 10850076289079 | Hysen Drug Test Cards | HDOA-154-021 | HDOA-154-021 | 2026-03-18 |
| 00850076289027 | HYSEN Multi-Panel Drug Test Dip Card | HDOA-1124A | HDOA-1124A | 2025-08-28 |
| 00850076289034 | HYSEN Fentanyl Rapid Test | HFYL-102A | HFYL-102A | 2025-08-28 |
| 00850076289041 | HYSEN Multiple Drugs Test Cup | HDOA-1177A | HDOA-1177A | 2025-08-28 |
| 10850076289024 | HYSEN Multi-Panel Drug Test Dip Card | HDOA-1124A | HDOA-1124A | 2025-08-28 |
| 10850076289048 | HYSEN Multiple Drugs Test Cup | HDOA-1177A | HDOA-1177A | 2025-08-28 |
| 10850076289000 | Hysen Drug Test Cups | HYD1141-011 | HYD1141-011 | 2025-08-04 |
| 10850076289017 | Hysen Drug Test Cards | HYD1122-011 | HYD1122-011 | 2025-08-04 |
| 00850076289003 | Hysen Drug Test Cups | HYD1141-011 | HYD1141-011 | 2025-08-04 |
| 00850076289010 | Hysen Drug Test Cards | HYD1122-011 | HYD1122-011 | 2025-08-04 |
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|---|---|---|---|---|
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| 10722066015084 | Rapid Response | BTNX Inc | NGL | 2026-05-15 |
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| 16936983170007 | Alltest Multi-Drug 12 Drugs Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-15 |
| 16936983170014 | Alltest Multi-Drug 13 Drugs Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-15 |
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