Identity
- Trade Name
- URiSCAN® 1 Ketones strip EUDAMEDURiSCAN 1 Ketones strip FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- URiSCAN® strip (Professional use) EUDAMEDUrinalysis dip and read strips for visual. Test for Ketones in urine. FDA UDI
- Model / Reference
- U15 EUDAMEDU151 FDA UDI
- Description
- Urinalysis dip and read strips for visual. Test for Ketones in urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806125680071 EUDAMEDFDA UDI
- Basic UDI-DI
- 88061256USTR-PYR EUDAMED
- 510(k) Number
- K952307 FDA UDI
- FDA Product Code
- JIN FDA UDI
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1435 FDA UDI
- Market of Registration
- Lithuania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
URiSCAN 1 Ketones strip by Yd Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.
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- TECO DIAGNOSTICS — TECO DIAGNOSTICS · Class I
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Yd Diagnostics
Sources (2)
- FDA UDI 20a08855-562f-44f8-9cb7-d1e32ee4183d 34 fields · synced Jun 18, 2026
- EUDAMED 57454d4e-190e-4096-877d-50f567c384df 61 fields · synced Jun 18, 2026