Reagent, Coronavirus Serological
Who Makes This Device Type in China?
12 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Guangdong and Hebei, and 1 other province. 2 of them are contract manufacturers, able to build to a buyer’s own specification.
- Assure Tech. (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- Biohit Healthcare (Hefei) Co., Ltd. Anhui, contract manufacturer
- Hangzhou Laihe Biotech Co., Ltd. Zhejiang, contract manufacturer
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
- Hangzhou Biotest Biotech Co., Ltd. Zhejiang, contract manufacturer
- Innovita (Tangshan) Biological Technology Co., Ltd. Hebei
- Shenzhen NEW Industries Biomedical Engineering Co., Ltd. Guangdong
- Shijiazhuang Hipro Biotechnology Co., Ltd. Hebei
- Shenzhen Lifotronic Technology Co., Ltd. Guangdong
- Shenzhen Watmind Medical Co., Ltd. Guangdong, contract manufacturer
- Zhejiang Gene Science Co., Ltd. Zhejiang
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
What Is This Device?
The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.
What Is FDA Product Code QKO?
Reagent, Coronavirus Serological is FDA product code QKO, not classified.
What Does It Take to Sell It in the United States?
This code was created for emergency use authorisation during the COVID-19 public health emergency; sale under it depended on the authorisation, not on a standard premarket submission.
What Has Gone Wrong With It?
The FDA has recorded 31 recalls under this product code since 2020. 1 was by a company in China. 3 are Class I, the most serious grade.
The root causes the FDA records most often are No Marketing Application (7), Nonconforming Material/Component (5) and Device Design (4). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.