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DVVconfirm 5 815

by Biomedica ADI Inc.

DVVconfirm 5 815 is a Class I device made by Biomedica ADI Inc., listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00850201006024), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850201006024 UDI-DI Date20 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  • Withdrawn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

Trade name
DVVconfirm 5
Generic name
Lupus anticoagulant marker IVD, kit, clotting
Model / Ref / Catalog
815
Primary DI / UDI-DI
00850201006024
FDA product code
GIR
GMDN term
Lupus anticoagulant marker IVD, kit, clotting
Device class
Class I
Regulation number
864.8950
GUDID distribution status
In Commercial Distribution

Related devices

Category: Lupus anticoagulant marker IVD, kit, clotting

Other devices from Biomedica ADI Inc.

See all devices from Biomedica ADI Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)