Identity
- Trade Name
- POINTE SCIENTIFIC Fructosamine Calibrator FDA UDI
- Generic Name
- Fructosamine IVD, calibrator FDA UDI
- Device Name
- The Fructosamine calibrator is derived from pooled human serum containing buffers, stabilizers and fillers. It is intended for use as a calibrator in the determination of fructosamine test systems to validate performance of the assay. FDA UDI
- Model / Reference
- F7546-CAL FDA UDI
- Description
- The Fructosamine calibrator is derived from pooled human serum containing buffers, stabilizers and fillers. It is intended for use as a calibrator in the determination of fructosamine test systems to validate performance of the assay. FDA UDI
Identifiers
- Catalog Number
- F7546-CAL FDA UDI
- Primary DI / UDI-DI
- 00811727011084 FDA UDI
- 510(k) Number
- K993590 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Fructosamine IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 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
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
Category: Fructosamine IVD, calibrator
POINTE SCIENTIFIC Fructosamine Calibrator by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fructosamine IVD, calibrator.
- Atellica CH Fruc Calibrator — Siemens Healthcare Diagnostics · Class II
- FRUC CAL — Randox Laboratories, Ltd. · Class II
- Fructosamine Calibrator — CLINIQA CORPORATION · Class I
Cleared under the same submission
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 7cd6f9b3-6da4-4c18-b09d-7a1299fcc7bb 37 fields · synced Jun 8, 2026