Identity
- Trade Name
- ACCU-CHEK GUIDE FDA UDI
- Generic Name
- Glucose IVD, kit, spectrophotometry FDA UDI
- Device Name
- ACCU-CHEK GUIDE METER ONLY MG/DL US FDA UDI
- Model / Reference
- 07400942001 FDA UDI
- Description
- ACCU-CHEK GUIDE METER ONLY MG/DL US FDA UDI
Identifiers
- Catalog Number
- 07400942001 FDA UDI
- Primary DI / UDI-DI
- 00365702702066 FDA UDI
- 510(k) Number
- K160944 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, kit, spectrophotometry
Accu-Chek Guide by Roche Diagnostics Operations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose IVD, kit, spectrophotometry.
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Cleared under the same submission
K160944 also covers:
- ACCU-CHECK GUIDE — Roche Diagnostics Operations, Inc.
- ACCU-CHEK GUIDE — Roche Diagnostics Operations, Inc.
- ACCU-CHEK GUIDE — Roche Diagnostics Operations, Inc.
- ACCU-CHEK GUIDE — Roche Diagnostics Operations, Inc.
- ACCU-CHEK GUIDE — Roche Diagnostics Operations, Inc.
- ACCU-CHEK GUIDE — Roche Diagnostics Operations, Inc.
- ACCU-CHEK GUIDE — Roche Diagnostics Operations, Inc.
- ACCU-CHEK GUIDE — Roche Diagnostics Operations, Inc.
- Accu-Chek Guide — Roche Diagnostics Operations, Inc.
- Accu-Chek Guide — Roche Diagnostics Operations, Inc.
- Accu-Chek Guide — Roche Diagnostics Operations, Inc.
- Accu-Chek Guide — Roche Diagnostics Operations, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Operations, Inc.
Sources (1)
- FDA UDI 96ee2869-4f5b-42c7-90bd-9d4b254d2f05 35 fields · synced May 30, 2026