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 |
|---|---|
| PTH | Test, Barbiturate, Over The Counter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K243996 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10850076289048 | Package | GS1 | 4 | In Commercial Distribution |
| 00850076289041 | Primary | GS1 | 0 | |
| 20850076289045 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10850076289048 | 10850076289048 | ||
| 00850076289041 | 00850076289041 | 850076289041 | 0850076289041 |
| 20850076289045 | 20850076289045 |
GMDN Terms#
| Term | Definition |
|---|---|
| Multiple drugs of abuse 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 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 |
|---|
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 | 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 |
| 10850076289031 | HYSEN Fentanyl Rapid Test | HFYL-102A | HFYL-102A | 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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