DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Dfi Co., Ltd
Identity
- Trade Name
- DUS 10 EUDAMED
- Device Name
- Dus Series EUDAMED
- Model / Reference
- DUS Series EUDAMED3064 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806141304791 EUDAMED
- Basic UDI-DI
- 88061413US33D0JN EUDAMED
- 510(k) Number
- K181024 FDA 510(k)
- FDA Product Code
- JIL FDA 510(k)
- EMDN Code
- W01010999 MULTIPLE PARAMETERS URINE TESTING - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1340 FDA 510(k)
- Regulation Number
- 862.1340 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
The DUS Reagent Strips are enzymatic, non-quantitative urinary glucose test strips designed for clinical chemistry applications. These devices detect the presence of glucose in urine samples without quantifying its concentration, aiding in preliminary screening for glycosuria.
Supplied as single-use strips in packs of 2, 5, or 10, these devices are intended for in vitro diagnostic use under the In Vitro Diagnostic Regulation (IVDR) and have received FDA 510(k) clearance as substantially equivalent. They are classified as Class II medical devices and require proper storage to maintain integrity before use.
Frequently asked questions
Are these reagent strips reusable or designed for single-use only?
The DUS Reagent Strips are explicitly designed for single-use only. Since they are enzymatic and non-quantitative urinary glucose test strips, each strip is intended to be used once per urine sample to detect glucose presence without quantifying it. Reuse could compromise accuracy and sterility, which are critical for reliable diagnostic results.
What pack sizes are available for the DUS Reagent Strips, and how are they supplied?
The DUS Reagent Strips are supplied in three pack sizes: 2 strips per pack (DUS 2GP), 5 strips per pack (DUS 5), and 10 strips per pack (DUS 10). Each pack contains individual, sealed strips to maintain sterility and integrity until use, ensuring optimal performance for clinical chemistry applications.
How should these reagent strips be stored to ensure they remain effective?
Proper storage is essential for maintaining the integrity of the DUS Reagent Strips. While the exact storage conditions aren’t detailed in the data, as Class II medical devices, they should be stored in a cool, dry place, protected from moisture, light, and extreme temperatures. Always follow the manufacturer’s instructions (DFI Co., Ltd.) to avoid degradation of the enzymatic reagents before use.
What regulatory pathways have these strips undergone, and how does that affect their use?
The DUS Reagent Strips have undergone FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent). They are also compliant with the In Vitro Diagnostic Regulation (IVDR) in the EU. This means they are classified as Class II devices and are intended for in vitro diagnostic use—specifically for preliminary screening of glycosuria in urine samples. Their regulatory status ensures they meet safety and performance standards for clinical chemistry applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181024 | Class II | Active |
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Manufacturer
- Manufacturer
- Dfi Co., Ltd
- FDA Applicant
- DFI Co., Ltd.
Sources (2)
- FDA 510(k) K181024 24 fields · synced Sep 18, 2026
- EUDAMED 1840eff7-a95d-4b29-a21f-a9b0418b1085 61 fields · synced Jul 10, 2026