ImmunoDOT Salmonella Typhi
The GenBio Salmonella typhi ImmunoDOT test is an enzyme immunoassay for the detection of antibodies to Salmonella (typhoid fever) for the serological confirmation of infections in serum,…
Antisera, Fluorescent, All Globulins, Salmonella Spp.
Which Manufacturers in China Make This?
3 manufacturers in China hold an FDA registration for this device type, based in Jilin.
- Changchun Merydi BIO-Tech Co., Ltd. Jilin
- Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
- Jilin Hongyi BIO-Tech Co., Ltd. Jilin
How Is GOO Classified?
Antisera, Fluorescent, All Globulins, Salmonella Spp. is FDA product code GOO, Class 2, 21 CFR 866.3550.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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