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ADVIA® Chemistry TRIG Triglycerides Reagents 10311837

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 Number00630414209708 UDI-DI Date21 Aug 2020ListedStatusListed 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  • Withdrawn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® Chemistry TRIG Triglycerides Reagents
Generic Name
Triglyceride IVD, kit, spectrophotometry
Model / Ref / Catalog
10311837, B01-4133-01
Description
Triglyceride - ADVIA Chem. - RGT - 4x575/4x450 tests
Primary DI / UDI-DI
00630414209708
510(k) Number
FDA Product Code
CDT
GMDN Term
Triglyceride IVD, kit, spectrophotometry
Device Class
Class I
Regulation Number
862.1705
GUDID distribution status
Not in Commercial Distribution

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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