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Cybow 11 Series Reagent Strips for Urinalysis

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K052525Ref 4C14Model CYBOW Series

by Dfi Co., Ltd

Identity

Device Name
CYBOW Series EUDAMED
Model / Reference
CYBOW Series EUDAMED
4C14 EUDAMED

Identifiers

Primary DI / UDI-DI
08806141302223 EUDAMED
Basic UDI-DI
88061413US31D0JC EUDAMED
510(k) Number
K052525 FDA 510(k)
FDA Product Code
JIL FDA 510(k)
EMDN Code
W01010999 MULTIPLE PARAMETERS URINE TESTING - OTHER EUDAMED

Classification

Device Class
Class B EUDAMED
Class 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

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

The Cybow 11 Series Reagent Strips for Urinalysis are enzymatic, non-quantitative test strips designed for the qualitative detection of glucose in urine. These strips fall under the classification of clinical chemistry devices, specifically for urinary analysis, and are intended for preliminary screening and diagnostic purposes in a laboratory or clinical setting.

These reagent strips are supplied as single-use, non-sterile devices and are regulated under FDA 510(k) clearance (K052525) and the In Vitro Diagnostic Regulation (IVDR). They are packaged for individual use and must be stored according to manufacturer instructions to maintain integrity. The device is classified as Class II under FDA regulations (862.1340) and is intended for use in clinical chemistry laboratories.

Frequently asked questions

What is the Cybow 11 Series Reagent Strips primarily used for in a clinical setting?

The Cybow 11 Series Reagent Strips are designed for the qualitative detection of glucose in urine, serving as a preliminary screening and diagnostic tool in laboratory or clinical settings. They are enzymatic, non-quantitative strips, meaning they provide a yes/no or color-based result rather than a numerical measurement.

Are these reagent strips intended for single-use or repeated testing?

These strips are explicitly labeled as single-use devices, meaning each strip should be used once and then discarded. This design ensures accuracy and prevents cross-contamination between tests.

How should the Cybow 11 Series Reagent Strips be stored to maintain their integrity?

The manufacturer’s instructions must be followed for storage, though the data does not specify exact conditions. Generally, reagent strips should be kept in a cool, dry place, protected from moisture and extreme temperatures, to preserve their performance and prevent degradation.

What regulatory pathways have been followed for this device?

The Cybow 11 Series Reagent Strips have undergone FDA 510(k) clearance (K052525) and comply with the In Vitro Diagnostic Regulation (IVDR). They are classified as Class II devices under FDA regulations (862.1340), indicating a moderate risk level requiring pre-market review.

Are these strips sterile, and if not, what precautions should be taken during use?

The Cybow 11 Series Reagent Strips are non-sterile, meaning they are not intended for invasive procedures or sterile field applications. Users should follow standard aseptic techniques (e.g., clean hands, uncontaminated urine sample) to minimize infection risk during urinalysis.

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. Sources consulted: CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS (K052525) — FDA 510 (k ..., CYBOW 11 Series Reagent Strips for Urinalysis - BestViewsReviews, Cybow 11 Series Reagent Strips for Urinalysis, CYBOW Urine Strips, Microalbumin/Creatinine Test Strips- DFI CO., LTD.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dfi Co., Ltd
FDA Applicant
DFI Co., Ltd.

Sources (2)

  • FDA 510(k) K052525 24 fields · synced Sep 18, 2026
  • EUDAMED 3034fa65-1ebf-4f63-8879-16907167ae21 61 fields · synced Jul 25, 2026