Identity
- Trade Name
- URiSCAN® 6 L strip EUDAMEDURiSCAN 6 L 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 and URiSCAN urine analyzer. Test for Blood, Protein, Nitrite, Glucose, pH and Leucocytes in urine. FDA UDI
- Model / Reference
- U25 EUDAMEDU251 FDA UDI
- Description
- Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Protein, Nitrite, Glucose, pH and Leucocytes in urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806125680064 EUDAMEDFDA UDI
- Basic UDI-DI
- 88061256USTR-PYR EUDAMED
- 510(k) Number
- K952307 FDA UDI
- FDA Product Code
- JIL FDA UDILJX FDA UDIJIO FDA UDICEN FDA UDIJIR FDA UDIJMT FDA UDI
- EMDN Code
- W0101060204,W0101060205 EUDAMED
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1340 FDA UDI864.7675 FDA UDI864.6550 FDA UDI862.1550 FDA UDI862.1645 FDA UDI862.1510 FDA UDI
- Market of Registration
- France 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 6 L strip by Yd Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.
- TECO DIAGNOSTICS — TECO DIAGNOSTICS · Class II
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- TECO DIAGNOSTICS — TECO DIAGNOSTICS · Class I
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Moore Medical — Moore Medical Corp. · Class I
- InstaTest — Diagnostic Automation, Inc. · Class I
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yd Diagnostics
Sources (2)
- FDA UDI 6dd3e45d-c251-428e-a4d9-00860fdc0a8a 34 fields · synced Jul 26, 2026
- EUDAMED cf91331a-c650-474c-9c4d-1ed3167bb353 61 fields · synced Jul 26, 2026