Identity
- Trade Name
- POINTE SCIENTIFIC Fructosamine Control Set FDA UDI
- Generic Name
- Fructosamine IVD, control FDA UDI
- Device Name
- These Fructosamine Controls are intended for use in fructosamine test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.1 For in vitro diagnostic use only. FDA UDI
- Model / Reference
- F7546-CTL FDA UDI
- Description
- These Fructosamine Controls are intended for use in fructosamine test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.1 For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- F7546-CTL FDA UDI
- Primary DI / UDI-DI
- 00811727011091 FDA UDI
- 510(k) Number
- K993590 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Fructosamine IVD, control 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, control
POINTE SCIENTIFIC Fructosamine Control Set by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fructosamine IVD, control.
- Diazyme — Diazyme Laboratories, Inc.
- CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 — Carolina Liquid Chemistries Corp. · Class II
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- Audit MicroControls Linearity DROP LQ Fructosamine for Roche Systems — Aalto Scientific, Ltd.
- FRUC CONTROL 1 — Randox Laboratories, Ltd. · Class I
- FRUC CONTROL 3 — Randox Laboratories, Ltd. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 81bc4fd4-fbdb-4767-8f48-3e59a27cd814 37 fields · synced May 30, 2026