Imagearainfluenza Virus Group (Types 1, 2 and 3) Test and Imagen Parainfluenza Virus Test Types 1, 2 and 3

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

510(k) Number

K981226 ↗

FDA Product Code

GQP

FDA applicant

Dako Diagnostics , Ltd.

Device Class

Class I

Regulation

21 CFR Part 866.3400

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Imagen

  Class I

  FDA 510(k) K943557 Active Cleared 9 Jan 1995

• Ideia(Tm) Rotavirus

  Class I

  FDA 510(k) K932384 Active Cleared 27 Dec 1993

• Imagen Respiratory Screen

  Class I

  FDA 510(k) K962037 Active Cleared 26 Dec 1996

• Ideia(Tm) Chlamydia Blocking Reagents, Modification

  Class I

  FDA 510(k) K940564 Active Cleared 11 Jan 1996

• Imagen Respiratory Screen

  Class I

  FDA 510(k) K973954 Active Cleared 22 Dec 1997