Immunohistochemistry Reagents And Kits

NJT · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.1860

Classification

FDA Product Code: NJT
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 864.1860
Review panel: PA
Medical specialty: Hematology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 47

Source

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