Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls FDA UDI
Generic Name: Multiple drugs of abuse IVD, calibrator FDA UDI
Device Name: Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls, 3 levels FDA UDI
Model / Reference: 10445390 FDA UDI
Description: Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls, 3 levels FDA UDI

Identifiers

Catalog Number: 7C219UL FDA UDI
Primary DI / UDI-DI: 00842768014321 FDA UDI
510(k) Number: K821743 FDA UDI
FDA Product Code: LFG FDA UDI
GMDN Term: Multiple drugs of abuse IVD, calibrator 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple drugs of abuse IVD, calibrator

Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K821743 also covers:

Syva® Emit® tox™ Serum Tricyclic Antidepressants Assay — Siemens Healthcare Diagnostics

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 ad1cfd7f-56fb-443b-88d3-15819b4c71d6 37 fields · synced Jun 1, 2026