Media, Culture, Ex Vivo, Tissue and Cell

What Is FDA Product Code NDS?

Media, Culture, Ex Vivo, Tissue And Cell is FDA product code NDS, Class 2, 21 CFR 876.5885.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 381 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 7 recalls under this product code since 2018. None was by a company in China. The root cause the FDA records most often is Vendor change control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.