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Buffer M 4402-0010

by Wallac Oy

Buffer M 4402-0010 is a Class I device made by Wallac Oy, listed in FDA GUDID since 17 Apr 2023 (UDI-DI 06438147386918), registry data as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06438147386918 UDI-DI Date17 Apr 2023ListedStatusListed 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  • Withdrawn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

Trade name
Buffer M
Generic name
Buffered sample diluent IVD
Model / Ref / Catalog
4402-0010
Primary DI / UDI-DI
06438147386918
FDA product code
PPM
GMDN term
Buffered sample diluent IVD
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Buffered sample diluent IVD

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Other devices filed under Buffered sample diluent IVD.

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Properties

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