Enzyme Immunoassay, Cannabinoids

How Is LDJ Classified?

Enzyme Immunoassay, Cannabinoids is FDA product code LDJ, Class 2, 21 CFR 862.3870.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 5 clearances under this code; the FDA took a median of 81 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 15 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Process control (7), Nonconforming Material/Component (3) and Storage (2).

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