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ADVIA Centaur® AFP 10998577

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00630414022963 UDI-DI Date12 Jul 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ADVIA Centaur® AFP
Generic Name
Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
10998577
Primary DI / UDI-DI
00630414022963
PMA Number
FDA Product Code
LOK
GMDN Term
Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (P930036)

Show all (11)

Other devices from Siemens Healthcare Diagnostics Inc.

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Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

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