Identity
- Trade Name
- Care Touch FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Blood Ketone Test strips FDA UDI
- Model / Reference
- CTk-50 FDA UDI
- Description
- Blood Ketone Test strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00370393001084 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
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
Yes
FDA UDI
Expiration Date
Yes
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.
- TECO DIAGNOSTICS — TECO DIAGNOSTICS · Class II
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- URiSCAN 1 Glucose strip — Yd Diagnostics · Class II
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- TECO DIAGNOSTICS — TECO DIAGNOSTICS · Class I
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Moore Medical — Moore Medical Corp. · Class I
Cleared under the same submission
K161738 also covers:
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
- Future Diagnostics Llc
Sources (1)
- FDA UDI 2e9842b9-3b4e-4a72-8b38-2bdce7a1d32f 35 fields · synced May 30, 2026