Test, Nitrite, Urinary, Non-Quantitative, Over the Counter
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Zhejiang. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
How Is NGJ Classified?
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter is FDA product code NGJ, Class 1, 21 CFR 862.1510.
What Does It Take to Sell It in the United States?
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. No clearance under this code names a Chinese applicant.
A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2023. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.