Identity
- Trade Name
- Minuteful - kidney test FDA UDI
- Generic Name
- Self-testing data clinician presentation application software IVD FDA UDI
- Device Name
- The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health. FDA UDI
- Model / Reference
- MNT KDN.US.GEN FDA UDI
- Description
- The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290017272471 FDA UDI
- 510(k) Number
- K210069 FDA UDI
- FDA Product Code
- JIR FDA UDIJFY FDA UDIKQO FDA UDI
- GMDN Term
- Self-testing data clinician presentation application software IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1645 FDA UDI862.1225 FDA UDI862.2900 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
Yes
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: Self-testing data clinician presentation application software IVD
Minuteful - kidney test by Healthy.io Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Healthy.io Ltd
Sources (1)
- FDA UDI 3f04a475-2f9e-4271-a614-d47f06c0fbcf 35 fields · synced May 30, 2026