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Syva® Emit® 2000 Valproic Acid Assay

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Syva® Emit® 2000 Valproic Acid Assay FDA UDI
Generic Name
Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Syva® Emit® 2000 Valproic Acid Assay FDA UDI
Model / Reference
10445312 FDA UDI
Description
Syva® Emit® 2000 Valproic Acid Assay FDA UDI

Identifiers

Catalog Number
4G019UL FDA UDI
Primary DI / UDI-DI
00842768000942 FDA UDI
510(k) Number
K002551 FDA UDI
FDA Product Code
LEG FDA UDI
GMDN Term
Valproic acid 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: Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® 2000 Valproic Acid Assay by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K002551 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 51b52495-bf45-4bfa-87e3-39ab45c06ef8 37 fields · synced Jun 1, 2026