Immunohistochemistry Assay, Antibody, Ki-67

QQT · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: QQT
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: PA
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens. The KI-67 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown