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D3 01-035005

by Diagnostic Hybrids, Inc.

D3 01-035005 is a medical device (FDA Class II; FDA product code OMG, Antisera, fluorescent, human metapneumovirus) made by Diagnostic Hybrids, Inc., listed in FDA GUDID since 7 Aug 2018 (UDI-DI 30014613330530), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30014613330530 UDI-DI Date7 Aug 2018ListedStatusListed 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  • Withdrawn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
D3
Generic name
Human metapneumovirus (hMPV) antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
01-035005
Primary DI / UDI-DI
30014613330530
FDA product code
OMG
GMDN term
Human metapneumovirus (hMPV) antigen IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.3980
GUDID distribution status
In Commercial Distribution

Related devices

Category: Human metapneumovirus (hMPV) antigen IVD, kit, fluorescent immunoassay

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

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