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Syva® Emit® 2000 Procainamide Assay

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Syva® Emit® 2000 Procainamide Assay FDA UDI
Generic Name
Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Syva® Emit® 2000 Procainamide Assay FDA UDI
Model / Reference
10445318 FDA UDI
Description
Syva® Emit® 2000 Procainamide Assay FDA UDI

Identifiers

Catalog Number
4K019UL FDA UDI
Primary DI / UDI-DI
00842768000980 FDA UDI
510(k) Number
K922914 FDA UDI
FDA Product Code
LAR FDA UDI
GMDN Term
Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3320 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: Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

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

Cleared under the same submission

K922914 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 1b4a7bd5-1e4c-4b6e-a9f2-62897a87b4f5 37 fields · synced May 30, 2026