FDA Classifies SARS-CoV-2 Serology Tests as Class II Medical Devices

The Food and Drug Administration has officially classified a specific type of blood test for past coronavirus infections into Class II. This classification applies to tests that detect antibodies, which indicate an immune response to the virus rather than an active infection.

Why it matters: This is primarily an administrative update that clarifies the rules for manufacturers making antibody tests. By placing these devices in Class II, the FDA allows other companies to market substantially equivalent tests using a simpler notification process rather than facing higher hurdles. It does not approve new tests but sets the standard for how they must be reviewed and labeled.

Who it affects

• Medical device manufacturers producing SARS-CoV-2 antibody tests

---

This action was issued by the FDA and published in the Federal Register; readers should check the original document for full details on labeling requirements and special controls.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document