Identity
- Trade Name
- BIOLIS 50i FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- BIOLIS 50i Superior 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. BIOLIS 50i Superior with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 50i Superior 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
- 50-01-0000 FDA UDI
- Description
- BIOLIS 50i Superior 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. BIOLIS 50i Superior with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 50i Superior 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
- 50-01-0000 FDA UDI
- Primary DI / UDI-DI
- 04580262040014 FDA UDI
- 510(k) Number
- K040958 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
- Not 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
No
FDA UDI
BIOLIS 50i is a cutting-edge clinical chemistry analyzer that automates various steps of manual analytical procedures, providing accurate and reliable results. With its advanced technology and intuitive interface, this device is ideal for medical laboratories and clinics.
Cleared under the same submission
K040958 also covers:
- Calibrator 1 — TOKYO BOEKI MEDISYS INC.
- Calibrator 2 — TOKYO BOEKI MEDISYS INC.
- Calibrator 2 — TOKYO BOEKI MEDISYS INC.
- Calibrator SET A, B — TOKYO BOEKI MEDISYS INC.
- Cl (Chloride) Electrode — TOKYO BOEKI MEDISYS INC.
- Dialysis Calibrator — TOKYO BOEKI MEDISYS INC.
- K (Potassium) Electrode — TOKYO BOEKI MEDISYS INC.
- Na (Sodium) Electrode — TOKYO BOEKI MEDISYS INC.
- Urine Calibrator Set — TOKYO BOEKI MEDISYS INC.
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 8a06d344-add2-4911-92d7-578252f5b41f 38 fields · synced Jun 28, 2026