Skip to content

Advanced Instruments RBC Reagent Filtration Kit 111014

by Advanced Instruments, LLC 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00816068020405 UDI-DI Date15 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0640-2019 FDA Class II initiated 7 Feb 2018

    RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Advanced Instruments RBC Reagent Filtration Kit
Generic Name
Syringe filter, clinical
Model / Ref / Catalog
111014
Primary DI / UDI-DI
00816068020405
510(k) Number
FDA Product Code
GKL
GMDN Term
Syringe filter, clinical
Device Class
Class II
Regulation Number
864.5200
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K152776)

Show all (11)

Other devices from Advanced Instruments, LLC

See all devices from Advanced Instruments, LLC →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: 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
  • Expiration Date: No
  • Manufacturing Date: No