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Syva® Emit® 2000 N-Acetylprocainamide Assay 10445321

by Siemens Healthcare Diagnostics Inc.

Ref 10445321Model IVDR_67_GLA_DUB-C_C_REAG_N-Acetylprocainamide Assay

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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/IVDR EUDAMED Number0405686901287VS Basic UDI-DI 00842768017421UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768017421 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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Emit 2000 N-Acetylprocainamide Assay EUDAMED
Syva® Emit® 2000 N-Acetylprocainamide Assay GUDID
Generic Name
N-acetyl procainamide (NAPA) IVD, kit, fluorescent immunoassay
Device Name
IVDR_67_GLA_DUB-C_C_REAG_N-Acetylprocainamide Assay
Model / Ref / Catalog
10445321, IVDR_67_GLA_DUB-C_C_REAG_N-Acetylprocainamide Assay, 4N019UL
Primary DI / UDI-DI
00842768017421
Basic UDI-DI
0405686901287VS
510(k) Number
FDA Product Code
LAN
EMDN Code
W0102080106 N-acetylprocainamide
GMDN Term
N-acetyl procainamide (NAPA) IVD, kit, fluorescent immunoassay
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.3320
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class II

Related devices

Category: N-acetyl procainamide (NAPA) IVD, kit, fluorescent immunoassay

Cleared under the same submission (K922915)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: 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