Identity
- Trade Name
- Syva® Emit® Carbamazepine Calibrators FDA UDI
- Generic Name
- Carbamazepine therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- Syva® Emit® 2000 Carbamazepine Calibrators FDA UDI
- Model / Reference
- 10445310 FDA UDI
- Description
- Syva® Emit® 2000 Carbamazepine Calibrators FDA UDI
Identifiers
- Catalog Number
- 4F109UL FDA UDI
- Primary DI / UDI-DI
- 00842768000935 FDA UDI
- 510(k) Number
- K913066 FDA UDI
- FDA Product Code
- KLT FDA UDI
- GMDN Term
- Carbamazepine therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3645 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: Carbamazepine therapeutic drug monitoring IVD, calibrator
Syva® Emit® Carbamazepine Calibrators by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbamazepine therapeutic drug monitoring IVD, calibrator.
Cleared under the same submission
K913066 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 0b2317c9-d9f3-4534-b26c-c5316b804688 37 fields · synced May 31, 2026