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,…

Registry build 21.09.26

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, plasma or heparinized whole blood. This test is intended to be performed by trained laboratory personnel only.

3manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

All of them in Jilin.

Chinese manufacturers registered for FDA product code GOO
Manufacturer City Province Registered as Device types
Changchun Wancheng BIO-Electron Co., Ltd. Changchun Jilin Contract manufacturer 34
Changchun Merydi BIO-Tech Co., Ltd. Changchun Jilin Manufacturer 24
Jilin Hongyi BIO-Tech Co., Ltd. Changchun Jilin Manufacturer 24

Record

Regulatory record for ImmunoDOT Salmonella typhi
Listed by Genbio, United States
FDA product code GOO
Device type Antisera, Fluorescent, All Globulins, Salmonella Spp.
Device class Class 2
Regulation 21 CFR 866.3550
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-09-24
Record revised 2026-04-20 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for ImmunoDOT Salmonella typhi
Catalogue number Size Status
800-4040 25 tests In distribution

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer