Skip to content

Advia Centaur AFP Reagents and Calibrators

by Siemens Healthcare Diagnostics, Inc.

PMA P930036510(k) K944701Ref 10309980Model IVDR_67_TTN_DUB-C_C_KIT_Alpha Fetoprotein

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

CE IVDR PMA 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA P930036↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), FDA PMA, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901798WQ Basic UDI-DI 00630414177335UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414177335 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMA PMA NumberP930036 Date29 Sep 1995ApprovedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK944701 Date21 Nov 1994ClearedStatusActive

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 22 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  • Withdrawn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), FDA PMA Active

Specification

EUDAMED · 510(k) · PMA · GUDID

Trade Name
ADVIA Centaur® AFP EUDAMEDGUDID
Advia Centaur Afp Reagents and Calibrators PMA
Generic Name
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS PMA
Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay GUDID
Device Name
IVDR_67_TTN_DUB-C_C_KIT_Alpha Fetoprotein
Model / Ref / Catalog
10309980, IVDR_67_TTN_DUB-C_C_KIT_Alpha Fetoprotein, 110764
FDA applicant
Diagnostic Reagents, Inc.
Primary DI / UDI-DI
00630414177335
Basic UDI-DI
0405686901798WQ
Unit of Use DI
00630414601724
PMA Number
510(k) Number
FDA Product Code
JIS PMA
LOK GUDID
EMDN Code
W0102039001 Alphafetoprotein
GMDN Term
Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class II PMA
Class III GUDID
Regulation
21 CFR Part 862.1150
EU market of registration
Germany
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMEDPMAGUDID
Generic NameEUDAMED
—
PMA
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
GUDID
Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
FDA Product CodeEUDAMED
—
PMA
JIS
GUDID
LOK
Device ClassEUDAMED
Class C
PMA
Class II
GUDID
Class III

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 AFP Reagents and Calibrators are clinical chemistry test kits used for the detection of alpha-fetoprotein, which is associated with neural tube defects. These components are designed to function as part of an immunoassay system to provide accurate diagnostic measurements.

This product is manufactured by Siemens Healthcare Diagnostics, Inc. and is authorized for use under FDA 510(k), FDA PMA, and IVDR regulatory frameworks. Users should follow standard laboratory protocols for the storage and application of these reagents and calibrators to ensure consistent performance.

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 is the primary use of the Advia Centaur AFP Reagents and Calibrators?

    These reagents and calibrators are used in clinical chemistry testing to detect alpha-fetoprotein, a marker often associated with the assessment of neural tube defects.

  • Who is the manufacturer of this device?

    The device is manufactured by Siemens Healthcare Diagnostics, Inc.

  • Is this product regulated for clinical use?

    Yes, the device is authorized under FDA 510(k), FDA PMA, and IVDR regulatory frameworks, confirming its status for clinical laboratory applications.

Properties

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

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human 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