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ADVIA® Chemistry wr CRP Wide Range C-Reactive Protein Reagents 10318309

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

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 Number00630414475707 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0295-04 FDA Unclassified (pre-2012) initiated 3 Dec 2003
    • Terminated Z-0296-04 FDA Unclassified (pre-2012) initiated 3 Dec 2003

    Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ADVIA® Chemistry wr CRP Wide Range C-Reactive Protein Reagents
Generic Name
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
10318309, B01-4800-01
Description
CRP - ADVIA Chem. - RGT - 2x220 tests
Primary DI / UDI-DI
00630414475707
510(k) Number
FDA Product Code
DCK
GMDN Term
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Device Class
Class II
Regulation Number
866.5270
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K001009)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

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