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Advanced Instruments OsmoPRO MAX Calibration Set 3MA552

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 Number00816068020566 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  • Withdrawn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 OsmoPRO MAX Calibration Set
Generic Name
Osmolality IVD, calibrator
Model / Ref / Catalog
3MA552
Primary DI / UDI-DI
00816068020566
FDA Product Code
JMZ
GMDN Term
Osmolality IVD, calibrator
Device Class
Class I
Regulation Number
862.1540
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: Advanced Instruments® OsmoPRO® MAX Automated Osmometer

Other devices from Advanced Instruments, LLC

See all devices from Advanced Instruments, LLC →

Properties

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

Other properties (9)

  • Sterile: 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