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US IVD 48 Spot Target 8604532

by Bruker Scientific LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841594110054 UDI-DI Date16 Sep 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  • Withdrawn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
US IVD 48 Spot Target
Generic Name
Microplate IVD
Model / Ref / Catalog
8604532
Primary DI / UDI-DI
00841594110054
FDA Product Code
PEX
GMDN Term
Microplate IVD
Device Class
Class II
Regulation Number
866.3361
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Peracetic Acid

Properties

  • Lot / Batch Number
  • Serial Number

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
  • Expiration Date: No
  • Manufacturing Date: No