Identity
- Trade Name
- Winx Health Inc FDA UDI
- Generic Name
- Urine test strip colour chart IVD FDA UDI
- Device Name
- Three UTI tests FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Three UTI tests FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860002060439 FDA UDI
- 510(k) Number
- K063295 FDA UDI
- FDA Product Code
- LJX FDA UDI
- GMDN Term
- Urine test strip colour chart IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.7675 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
Yes
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: Urine test strip colour chart IVD
Winx Health Inc by Get Stix Inc. — 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
- Get Stix Inc.
Sources (1)
- FDA UDI b8388dcc-cdde-4603-a4bb-47e3142ccc03 35 fields · synced Jun 1, 2026