Identity
- Trade Name
- GLUCOSE FDA UDI
- Generic Name
- Glucose IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- SK235-10 FDA UDI
Identifiers
- Catalog Number
- SK235-10 FDA UDI
- Primary DI / UDI-DI
- 00628063400539 FDA UDI
- 510(k) Number
- K961282 FDA UDI
- FDA Product Code
- CFR FDA UDI
- GMDN Term
- Glucose IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Glucose by Sekisui Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K961282 also covers:
- Pointe Glucose Hexokinase for BS480 — POINTE SCIENTIFIC, INC.
- Pointe Glucose Reagent — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- GLUCOSE-SL — Sekisui Diagnostics, LLC
- GLUCOSE-SL Assay — Sekisui Diagnostics, LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Sekisui Diagnostics, LLC
Sources (1)
- FDA UDI 0113a1e4-349f-41a4-ba1c-257d1b75a350 35 fields · synced Jun 9, 2026