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Syva® Emit® Carbamazepine Assay

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Syva® Emit® Carbamazepine Assay FDA UDI
Generic Name
Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Syva® Emit® Carbamazepine Assay FDA UDI
Model / Reference
10445309 FDA UDI
Description
Syva® Emit® Carbamazepine Assay FDA UDI

Identifiers

Catalog Number
4F019UL FDA UDI
Primary DI / UDI-DI
00842768000928 FDA UDI
510(k) Number
K913066 FDA UDI
FDA Product Code
KLT FDA UDI
GMDN Term
Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) 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, kit, enzyme immunoassay (EIA)

Syva® Emit® Carbamazepine Assay 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, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K913066 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI d78e58ae-032b-4ec5-8929-570669d50881 37 fields · synced Jun 6, 2026