Identity
- Trade Name
- URiSCAN 10 SGL strip FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Leucocytes, Nitrite, Urobilinogen, Glucose, pH, Blood, SG(Specific Gravity), Ketones(Acetoacetic Acid), Bilirubin and Protein in urine. FDA UDI
- Model / Reference
- U774 FDA UDI
- Description
- Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Leucocytes, Nitrite, Urobilinogen, Glucose, pH, Blood, SG(Specific Gravity), Ketones(Acetoacetic Acid), Bilirubin and Protein in urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806125680217 FDA UDI
- 510(k) Number
- K952307 FDA UDI
- FDA Product Code
- CDM FDA UDICEN FDA UDIJIN FDA UDIJIO FDA UDIJIR FDA UDIJJB FDA UDIJMT FDA UDILJX FDA UDIJRE FDA UDIJIL FDA UDI
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1785 FDA UDI862.1550 FDA UDI862.1435 FDA UDI864.6550 FDA UDI862.1645 FDA UDI862.1115 FDA UDI862.1510 FDA UDI864.7675 FDA UDI862.2800 FDA UDI862.1340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
URiSCAN 10 SGL strip by Yd Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Yd Diagnostics
Sources (1)
- FDA UDI 0ed128d8-fb49-47b6-8677-90cfeabef8ff 34 fields · synced Jun 1, 2026