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ADVIA Centaur HAV IgM Assay

by Siemens Healthcare Diagnostics, Inc.

510(k) K161964Ref 10309083Model IVDR_67_TTN_DUB-C_B_KIT_aHAVM

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161964↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900747VY Basic UDI-DI 00630414479996UDI-DIDate22 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK161964 Date13 Oct 2016ClearedStatusActive
United StatesGUDID listing GUDID Number00630414479996 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 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
ADVIA Centaur® HAV IgM
Generic Name
Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_B_KIT_aHAVM
Model / Ref / Catalog
10309083, IVDR_67_TTN_DUB-C_B_KIT_aHAVM, 5004126
Primary DI / UDI-DI
00630414479996
Basic UDI-DI
0405686900747VY
510(k) Number
FDA Product Code
LOL
EMDN Code
W0105020104 Hav antibody igm
GMDN Term
Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Device Class
Class B EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 866.3310
EU market of registration
Germany
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class B
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ADVIA Centaur HAV IgM Assay is an in vitro diagnostic immunoassay designed for the qualitative detection of IgM antibodies in response to hepatitis A virus (HAV) infection. It is classified under microbiology assays and functions as a diagnostic tool to aid in identifying acute HAV exposure in human serum or plasma samples, including those collected with potassium EDTA, lithium heparin, or sodium heparin.

This assay is intended for use on the ADVIA Centaur XP and ADVIA Centaur XPT systems and is supplied as a single-use reagent. It has received FDA 510(k) clearance and is compliant with the In Vitro Diagnostic Regulation (IVDR). The device is not intended for MRI environments and requires proper storage as per manufacturer guidelines to maintain performance integrity.

Other devices from Siemens Healthcare Diagnostics

See all devices from Siemens Healthcare Diagnostics →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of patient samples can the ADVIA Centaur HAV IgM Assay detect hepatitis A virus IgM antibodies in?

    The ADVIA Centaur HAV IgM Assay is designed for qualitative detection of IgM antibodies in human serum or plasma samples. It accepts samples collected with potassium EDTA, lithium heparin, or sodium heparin, ensuring compatibility with common anticoagulants used in clinical testing.

  • Is this assay intended for use with any specific diagnostic platforms, and if so, which ones?

    Yes, the ADVIA Centaur HAV IgM Assay is specifically intended for use on the ADVIA Centaur XP and ADVIA Centaur XPT systems. These platforms are required to perform the assay as part of the diagnostic workflow.

  • How is the ADVIA Centaur HAV IgM Assay supplied, and is it reusable?

    The assay is supplied as a single-use reagent, meaning each test requires a new reagent cartridge. This design ensures consistency and reduces the risk of cross-contamination, which is critical for accurate diagnostic results.

  • What storage conditions are recommended to maintain the performance integrity of this assay?

    While the exact storage conditions are not detailed in the provided data, the manufacturer guidelines emphasize proper storage to maintain performance integrity. Typically, such assays require refrigeration (e.g., 2–8°C) and protection from light and moisture until use, though clinicians should refer to the official package insert for precise instructions.

Properties

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

Other properties (18)

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