Identity
- Trade Name
- Fresh Test FDA UDI
- Generic Name
- Glucose monitoring system IVD, point-of-care FDA UDI
- Device Name
- Fresh Test 50g Powder Glucose Tolerance Test FDA UDI
- Model / Reference
- 50g Powder FDA UDI
- Description
- Fresh Test 50g Powder Glucose Tolerance Test FDA UDI
Identifiers
- Catalog Number
- 27102055 FDA UDI
- Primary DI / UDI-DI
- G2192710205516 FDA UDI
- FDA Product Code
- MRV FDA UDI
- GMDN Term
- Glucose monitoring system IVD, point-of-care 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fresh Test 50g Powder Glucose Tolerance Test is a reliable and accurate device for measuring glucose levels in whole blood samples. It's a point-of-care test designed to help manage blood glucose levels, particularly for individuals with diabetes mellitus.
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
- Fresh Test, LLC
Sources (1)
- FDA UDI 54358621-5558-40e0-b241-863c07d9b478 35 fields · synced Jul 31, 2026