MCCClass II

Dna-Probe, Haemophilus Spp.

21 CFR 866.3300 / Microbiology

MCC is the FDA product code for Dna-Probe, Haemophilus Spp., a class II device type, regulated under 21 CFR 866.3300. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1990-06-20, and no recalls.

Classification record

Product code: MCC
Device name: Dna-Probe, Haemophilus Spp.
Regulation: 21 CFR 866.3300
Device class: Class II
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code MCC

By decision year

2 clearances under product code MCC with a decision year between 1990 and 1990, 1990 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code MCC by decision year
Year	Clearances
1990	2

Applicants with the most clearances

Product code MCC

Applicants holding the most 510(k) clearances under product code MCC
Applicant	Clearances
Hologic, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MCC.

Recent clearances

Product code MCC

Recent recalls

Product code MCC

FDA records show no recalls under product code MCC.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)