Identity
- Trade Name
- Accu-Chek Guide Link FDA UDI
- Generic Name
- Glucose IVD, kit, spectrophotometry FDA UDI
- Device Name
- ACCU-CHEK GUIDE LINK MG/DL 118 (US) FDA UDI
- Model / Reference
- 08109257001 FDA UDI
- Description
- ACCU-CHEK GUIDE LINK MG/DL 118 (US) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00365702702134 FDA UDI
- PMA Number
- P160017 FDA UDI
- FDA Product Code
- OZP FDA UDI
- GMDN Term
- Glucose IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class III 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, kit, spectrophotometry
Accu-Chek Guide Link by Roche Diagnostics Operations, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, kit, spectrophotometry.
- ADVIA® Chemistry GLUO Glucose Oxidase Reagents — Siemens Healthcare Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PRODUCT NO. DT208 — Carolina Liquid Chemistries Corp. · Class II
- Yumizen C1200 Glucose HK — Horiba Abx · Class II
- Atellica CH GluO — Siemens Healthcare Diagnostics · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Glucose HK — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Dimension Vista® Flex® reagent cartridge GLU — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
P160017 also covers:
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT LINK 2.4 — ASCENSIA DIABETES CARE US INC.
- Enlite ® — MEDTRONIC MINIMED, INC.
- Guardian ™ Sensor (3) — MEDTRONIC MINIMED, INC.
- Guardian ™ Sensor (3) — MEDTRONIC MINIMED, INC.
- Guardian ™ Sensor (3) — MEDTRONIC MINIMED, INC.
- Guardian™ 4 — MEDTRONIC MINIMED, INC.
- Guardian™ 4 — MEDTRONIC MINIMED, INC.
- Guardian™ 4 Transmitter — MEDTRONIC MINIMED, INC.
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Operations, Inc.
Sources (1)
- FDA UDI c17b8e9f-d419-4db4-9fe0-d97fd1ac210f 34 fields · synced Jun 8, 2026