Skip to content

Binax Now Malaria Test; Model 660-000, 660-Xxx

by Inverness Medical Professional Diagnostics-Binax

De Novo DEN070006

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Post-NSE NumberDEN070006 Date13 Jun 2007DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
OAX
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 866.3402
Advisory Committee
Microbiology
FDA Decision
DENG De Novo granted

Other devices from Inverness Medical Professional Diagnostics-Binax