Identity
- Trade Name
- DZ-Lite c270 FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. DZ-Lite c270 with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, DZ-Lite c270 with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. FDA UDI
- Model / Reference
- 60-01-9002 FDA UDI
- Description
- DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. DZ-Lite c270 with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, DZ-Lite c270 with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. FDA UDI
Identifiers
- Catalog Number
- 60-01-9002 FDA UDI
- Primary DI / UDI-DI
- 04580262049819 FDA UDI
- 510(k) Number
- K103531 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple clinical chemistry analyser IVD, laboratory
DZ-Lite c270 by Tokyo Boeki Medisys Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103531 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
- Tokyo Boeki Medisys Inc.
Sources (1)
- FDA UDI 0058eaac-fe67-4b3d-ab4d-02ac98fcdad9 37 fields · synced May 30, 2026