Identity
- Trade Name
- ONLINE TDM Amikacin FDA UDI
- Generic Name
- Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 08105383190 FDA UDI
Identifiers
- Catalog Number
- 08105383190 FDA UDI
- Primary DI / UDI-DI
- 07613336133514 FDA UDI
- 510(k) Number
- K032279 FDA UDI
- FDA Product Code
- KLP FDA UDI
- GMDN Term
- Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3035 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
ONLINE TDM Amikacin by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry.
- Alinity — Abbott Laboratories, Inc. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K032279 also covers:
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 Corp.
Sources (1)
- FDA UDI decaedb6-f9c9-4bd6-8b8d-95d1d5dadb8a 35 fields · synced Jun 1, 2026