Identity
- Trade Name
- TDM CAL FDA UDI
- Generic Name
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- This product is intended for use in the calibration of therapeutic drug assays. FDA UDI
- Model / Reference
- TD3417 FDA UDI
- Description
- This product is intended for use in the calibration of therapeutic drug assays. FDA UDI
Identifiers
- Catalog Number
- TD3417 FDA UDI
- Primary DI / UDI-DI
- 05055273206470 FDA UDI
- 510(k) Number
- K012318 FDA UDI
- FDA Product Code
- DKB FDA UDI
- GMDN Term
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-therapy therapeutic drug monitoring IVD, calibrator
Tdm Cal by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple-therapy therapeutic drug monitoring IVD, calibrator.
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- Atellica CH TDM Calibrator — Siemens Healthcare Diagnostics · Class II
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- Alinity — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K012318 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI c8a258f7-cd97-4127-958a-a3d55bcbfd93 37 fields · synced Jun 8, 2026