Identity
- Trade Name
- GlucoLin FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- GlucoLin is an assayed quality control material for professional use to verify the performance characteristics of HemoCue® Glucose systems. Glucolin is intended for the quantitative determination of glucose. A box of GlucoLin contains 5 levels of control material: GlucoLin XLow: 08718734961352 GlucoLin Low: 08718734961369 GlucoLin Normal: 08718734961376 GlucoLin High: 08718734961383 GlucoLin XHigh: 08718734961390 FDA UDI
- Model / Reference
- 025.000.005 FDA UDI
- Description
- GlucoLin is an assayed quality control material for professional use to verify the performance characteristics of HemoCue® Glucose systems. Glucolin is intended for the quantitative determination of glucose. A box of GlucoLin contains 5 levels of control material: GlucoLin XLow: 08718734961352 GlucoLin Low: 08718734961369 GlucoLin Normal: 08718734961376 GlucoLin High: 08718734961383 GlucoLin XHigh: 08718734961390 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718734961406 FDA UDI
- 510(k) Number
- K963909 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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, control
GlucoLin by Eurotrol B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, control.
- WowGoHealth Control Solution - GSH-BGM902 - Level 1 — GOLDEN SMART HOME TECHNOLOGY CORP. · Class I
- OneTouch Ultra Plus — Lifescan Europe · Class II
- TRUE METRIX — TRIVIDIA HEALTH, INC. · Class I
- Oh'Care Lite Smart Glucose control solution-Level 1 — OSANG HEALTHCARE Co., Ltd. · Class I
- TRUE FOCUS — TRIVIDIA HEALTH, INC. · Class I
- Tyson Bio HS100 Control Solution (Level 1) — TYSON BIORESEARCH INC. · Class II
- ACCU-CHEK Inform II — Roche Diagnostics Operations, Inc. · Class I
- Assure® Prism Control Solution — ARKRAY USA, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eurotrol B.V.
Sources (1)
- FDA UDI 33d067a9-b8f9-4eff-8caa-30fcce4f9d4f 34 fields · synced May 30, 2026