Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test | Federal Regulations · Congress.wiki

Rulemaking

FDA

RIN Not Assigned

FDA-2026-N-6712

Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test

Documents

Comments

Description

This order is classifying the SARS-CoV-2 serology test into class II (special controls).

Comment Period OpensJun 26, 2026

Type	Title	Posted	Comments	Status
Final Rule	Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test FR Doc: 2026-12902	Jun 26, 2026	--

2026-140

CDRH

Medical Devices

Immunology and Microbiology Devices

Classification of the SARS-CoV-2 Serology Test

OPEN