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Syva® Emit® Disopyramide Assay 10445370

by Siemens Healthcare Diagnostics Inc.

Ref 10445370Model DX_LS_LEGACY_00842768001406

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00842768001406 Basic UDI-DI 00842768001406UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768001406 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2880-2026 FDA Class III initiated 26 Jun 2026

    Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Emit Disopyramide Assay EUDAMED
Syva® Emit® Disopyramide Assay GUDID
Generic Name
Disopyramide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Device Name
DX_LS_LEGACY_00842768001406
Model / Ref / Catalog
10445370, DX_LS_LEGACY_00842768001406, 6N319UL
Primary DI / UDI-DI
00842768001406
Basic UDI-DI
B-00842768001406
510(k) Number
FDA Product Code
KLR
EMDN Code
W0102080103 Disopyramide
GMDN Term
Disopyramide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.3555
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Related devices

Category: Disopyramide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Other devices from Siemens Healthcare Diagnostics Inc.

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Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No