Identity
- Trade Name
- Thermo Scientific Trutol™ FDA UDI
- Generic Name
- Glucose IVD, reagent FDA UDI
- Model / Reference
- 401025P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845275004052 FDA UDI
- 510(k) Number
- K032753 FDA UDI
- FDA Product Code
- MRV FDA UDI
- GMDN Term
- Glucose IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, reagent
Thermo Scientific Trutol™ by Fisher Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose IVD, reagent.
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- GLUC-PAP — Randox Laboratories, Ltd. · Class II
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- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Glucose Tolerance Beverage — AZER SCIENTIFIC INCORPORATED · Class II
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- Vive Precision — VIVE HEALTH LLC · Class II
- GoChek2 — Microtech Medical (Hangzhou) Co., Ltd. · Class II
Cleared under the same submission
K032753 also covers:
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Thermo Scientific GlucoCrush™ — Fisher Diagnostics
- Thermo Scientific GlucoCrush™ — Fisher Diagnostics
- Thermo Scientific GlucoCrush™ — Fisher Diagnostics
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
- Fisher Diagnostics
Sources (1)
- FDA UDI d4d3232d-ce47-48dd-b97f-5cd8bab66b87 35 fields · synced Jun 8, 2026