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Syva® Emit® tox™ Serum Tricyclic Antidepressants Assay

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Syva® Emit® tox™ Serum Tricyclic Antidepressants Assay FDA UDI
Generic Name
Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Syva® Emit® tox Serum Tricyclic Antidepressants Assay FDA UDI
Model / Reference
10445389 FDA UDI
Description
Syva® Emit® tox Serum Tricyclic Antidepressants Assay FDA UDI

Identifiers

Catalog Number
7C209UL FDA UDI
Primary DI / UDI-DI
00842768014314 FDA UDI
510(k) Number
K821743 FDA UDI
FDA Product Code
LFG FDA UDI
GMDN Term
Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3910 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: Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® tox™ Serum Tricyclic Antidepressants Assay by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K821743 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 cc9c9262-48c8-44a9-b27c-7882bbca8922 37 fields · synced May 30, 2026