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Advanced Instruments BR2 Sample Diluent

by Advanced Instruments, LLC

Advanced Instruments BR2 Sample Diluent (B2A101D) is a Class II device made by Advanced Instruments, LLC, listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816068020078), registry data as of 19 Oct 2026.

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

Source GUDID, synced 19 Oct 2026.

Regulatory status

as of registry sync 19 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816068020078 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Model / reference
B2A101D
Primary DI / UDI-DI
00816068020078
FDA product code
CIG
GMDN term
Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Device class
Class II
Regulation number
862.1110
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: Advanced Instruments® OsmoTECH® XT Single-Sample Micro-Osmometer

Related devices

Category: Conjugated (direct) bilirubin IVD, kit, spectrophotometry

Similar devices in this category

Other devices filed under Conjugated (direct) bilirubin IVD, kit, spectrophotometry.

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)