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Advanced Instruments Renol 2 Level Urine Osmolality Control 3LA085

by Advanced Instruments, LLC

Listed FDA GUDID listing, no authorization on record

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 Number00816068020887 UDI-DI Date17 Sep 2026ListedStatusListed GUDID: 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  • Withdrawn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
Advanced Instruments Renol 2 Level Urine Osmolality Control
Generic Name
Red blood cell separation reagent
Model / Ref / Catalog
3LA085
Primary DI / UDI-DI
00816068020887
FDA Product Code
JMZ
GMDN Term
Red blood cell separation reagent
Device Class
Class I
Regulation Number
862.1540
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: Advanced Instruments® Bioprocess Calibrators & Controls

Other devices from Advanced Instruments, LLC

See all devices from Advanced Instruments, LLC →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • 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
  • Serial Number: No