Identity
- Trade Name
- UCARE 11 Stick FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Urinalysis dip and read strips for urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity) , Leucocytes and Ascorbic acid in urine. FDA UDI
- Model / Reference
- P411 FDA UDI
- Description
- Urinalysis dip and read strips for urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity) , Leucocytes and Ascorbic acid in urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806125680279 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 UDIJMA 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 UDI862.1095 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
UCARE 11 Stick 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 7def080a-0bcd-41e8-91c2-1b6cf7f44f58 34 fields · synced Jun 8, 2026