Identity
- Trade Name
- Atellica CH TDM Calibrator FDA UDI
- Generic Name
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- TDM Calibrator Atellica CH - CAL 5 x 2 x 3.0mL FDA UDI
- Model / Reference
- 11099439 FDA UDI
- Description
- TDM Calibrator Atellica CH - CAL 5 x 2 x 3.0mL FDA UDI
Identifiers
- Catalog Number
- 11099439 FDA UDI
- Primary DI / UDI-DI
- 00630414597607 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
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
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
Atellica CH TDM Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-therapy therapeutic drug monitoring IVD, calibrator.
- Plasma Calibration Standard — Chromsystems Instruments & Chemicals GmbH · Class II
- TDM CAL — Randox Laboratories, Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Plasma Calibrator Set — Chromsystems Instruments & Chemicals GmbH · Class II
- Plasma Calibration Standard — Chromsystems Instruments & Chemicals GmbH · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- Synchron — Beckman Coulter, Inc. · Class II
- Plasma Calibration Standard — Chromsystems Instruments & Chemicals GmbH · 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 26d0867b-1884-46c3-8b6c-3b77f4094aa2 37 fields · synced Jun 1, 2026