Identity
- Trade Name
- Accu-Chek Inform II Base Unit Light FDA UDI
- Generic Name
- Metabolic profile clinical chemistry analyser IVD, stationary, automated FDA UDI
- Model / Reference
- 08372284001 FDA UDI
Identifiers
- Catalog Number
- 08372284001 FDA UDI
- Primary DI / UDI-DI
- 07613336155332 FDA UDI
- 510(k) Number
- K121679 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD, stationary, automated 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
Yes
FDA UDI
Over-the-Counter
Yes
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: Metabolic profile clinical chemistry analyser IVD, stationary, automated
Accu-Chek Inform II Base Unit Light by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metabolic profile clinical chemistry analyser IVD, stationary, automated.
- Accu-Chek Inform II Base Unit Light — Roche Diagnostics Corp. · Class II
- cobas b 123 <2> POC system — Roche Diagnostics Corp. · Class II
- cobas b 221 <2> system — Roche Diagnostics Corp. · Class II
- cobas b 123 <4> POC system — Roche Diagnostics Corp. · Class II
- cobas b 221 <4> system — Roche Diagnostics Corp. · Class II
- cobas b 221 <6> system — Roche Diagnostics Corp. · Class II
- cobas b 123 <1> POC system — Roche Diagnostics Corp. · Class II
- cobas b 123 <3> POC system — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K121679 also covers:
- Accu-Chek Inform II Base Unit — Roche Diagnostics Corp.
- Accu-Chek Inform II Base Unit — Roche Diagnostics Corp.
- Accu-Chek Inform II Base Unit Light — Roche Diagnostics Corp.
- Accu-Chek Inform II Base Unit Light — Roche Diagnostics Corp.
- Accu-Chek Inform II Base Unit Light — Roche Diagnostics Corp.
- Accu-Chek Inform II Instrument with RF card — Roche Diagnostics Corp.
- Accu-Chek Inform II Instrument with RF card — Roche Diagnostics Corp.
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 1f8b7497-0acd-4ab9-ad1f-9d7a6f8a2ad9 34 fields · synced Jun 8, 2026