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Care Touch

FDA UDI

Class I (US FDA UDI)

by Future Diagnostics Llc

Identity

Trade Name
Care Touch FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Blood Ketone Monitoring system FDA UDI
Model / Reference
CTk-215 FDA UDI
Description
Blood Ketone Monitoring system FDA UDI

Identifiers

Primary DI / UDI-DI
00370393215207 FDA UDI
510(k) Number
K161738 FDA UDI
FDA Product Code
JIN FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Care Touch by Future Diagnostics Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K161738 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Future Diagnostics Llc

Sources (1)

  • FDA UDI 1ee8d519-95b5-4f0a-9a7b-13c230067191 35 fields · synced May 30, 2026