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Vantera Clinical Analyzer 9900300

by Labcorp of America

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 NumberB3959900300 UDI-DI Date11 Nov 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Vantera Clinical Analyzer
Generic Name
Lipid profile analyser IVD, laboratory, automated
Model / Ref / Catalog
9900300
Primary DI / UDI-DI
B3959900300
FDA Product Code
LBS, NSU, MRR, CDT
GMDN Term
Lipid profile analyser IVD, laboratory, automated
Device Class
Class I
Regulation Number
862.1475, 862.2570, 862.1705
GUDID distribution status
Not in Commercial Distribution

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No