Fiax C4 Assay

by Idt, A Division of Whittaker M.A. Bioproducts 510(k)

Active United States

510(k) K772114

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK772114	Date30 Nov 1977Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number: K772114
FDA Product Code: DAK

Device Class: Class II
Regulation: 21 CFR Part 866.5240
Advisory Committee: Immunology
FDA Decision: SESE Substantially Equivalent

Other devices from Idt, A Division of Whittaker M.A. Bioproducts

Fiax Test Kit for Measles-G Antibodies Flyorescent

Class I
Fiax Test Kit

Class II
Fiax Test Kit for Varicella Antibody Serology

Class II
Fiax Test for Anti-Rubella Antibody

Class II