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Atellica CH Albumin (Alb)

by Siemens Healthcare Diagnostics Inc.

Ref 11645757Model IVDR_67_TTN_DUB-C_B_REAG_ALB_c

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

Recall on shared 510(k) K991576; other models may be affected

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 Number0405686901648W4 Basic UDI-DI 00630414654140UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414654140 UDI-DI Date18 Mar 2026ListedStatusListed 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

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1498-2022 FDA Class II initiated 28 Jun 2022 on shared 510(k) K991576

    Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

    • Terminated Z-2062-2018 FDA Class II initiated 27 Mar 2018 on shared 510(k) K991576

    Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.

    • Terminated Z-1658-2016 FDA Class II initiated 17 Mar 2016 on shared 510(k) K991576

    Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
Atellica CH Albumin (Alb) EUDAMED
Atellica CH Alb GUDID
Generic Name
Albumin IVD, kit, nephelometry/turbidimetry
Device Name
IVDR_67_TTN_DUB-C_B_REAG_ALB_c
Model / Ref / Catalog
IVDR_67_TTN_DUB-C_B_REAG_ALB_c, 11645757
Primary DI / UDI-DI
00630414654140
Basic UDI-DI
0405686901648W4
Unit of Use DI
00630414322087
510(k) Number
FDA Product Code
CIX
EMDN Code
W01010201 Albumin (cc)
GMDN Term
Albumin IVD, kit, nephelometry/turbidimetry
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.1035
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000016560
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: 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