Identity
- Trade Name
- Easy@Home KetoneTest Strips (100 test kit) FDA UDI
- Generic Name
- Ketone (acetoacetate) IVD, calibrator FDA UDI
- Device Name
- Easy@Home KetoneTest Strips; Reagent Strips for Urinalysis; Ideal for Keto Diet; 100 ct FDA UDI
- Model / Reference
- EZR-101 FDA UDI
- Description
- Easy@Home KetoneTest Strips; Reagent Strips for Urinalysis; Ideal for Keto Diet; 100 ct FDA UDI
Identifiers
- Catalog Number
- EZR-101-100 FDA UDI
- Primary DI / UDI-DI
- 00855944007239 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Ketone (acetoacetate) IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1435 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
Yes
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: Ketone (acetoacetate) IVD, calibrator
Easy@Home KetoneTest Strips (100 test kit) by Easy Healthcare Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ketone (acetoacetate) IVD, calibrator.
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
- Easy Healthcare Corporation
Sources (1)
- FDA UDI c31af5b5-4429-48a3-b951-1bf50d8109ba 34 fields · synced Jun 8, 2026