Easy@Home Urinary Tract Infection Test Strips (10 Pack)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Easy@Home Urinary Tract Infection Test Strips (10 Pack) FDA UDI
- Generic Name
- Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Easy@Home Urinary Tract Infection Test Strips (10 Pack) FDA UDI
- Model / Reference
- EZU-101 FDA UDI
- Description
- Easy@Home Urinary Tract Infection Test Strips (10 Pack) FDA UDI
Identifiers
- Catalog Number
- EZU-101-10 FDA UDI
- Primary DI / UDI-DI
- 00810038631448 FDA UDI
- 510(k) Number
- K063295 FDA UDI
- FDA Product Code
- LJX FDA UDIJMT FDA UDI
- GMDN Term
- Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.7675 FDA UDI862.1510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
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 urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)Multiple urinary tract pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Easy@Home Urinary Tract Infection Test Strips (10 Pack) by Easy Healthcare Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT).
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Easy Healthcare Corporation
Sources (1)
- FDA UDI ff433665-1815-427a-b91d-30f619cea853 35 fields · synced Jun 1, 2026