Microbiological Research Corp.
United StatesFDA applicant, unverified
- Devices
- 14
What Microbiological Research Corp. makes
Microbiological Research Corp. manufactures serological reagents and diagnostic tests for infectious diseases, including tests for Epstein-Barr virus (EBV), cytomegalovirus (CMV), toxoplasmosis, rubella, and herpes simplex virus (HSV). Their portfolio includes labeled antibodies, such as anti-human IgG conjugated with FITC, and multi-analyte panels like the Golden Quad Test series for simultaneous detection of CMV, EBV, HSV, and toxoplasmosis. Additional offerings include specific serological reagents for rubella virus and herpesvirus type 1 and 2, as well as IgM tests for CMV.
The company’s diagnostic reagents are regulated under the FDA’s 510(k) pathway, with devices classified as either Class I or Class II. Their products are listed in the FDA’s 510(k) database, indicating compliance with U.S. regulatory requirements for in vitro diagnostic (IVD) devices. The company is based in the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Microbiological Research Corp. have in the registry?
The registry currently lists 14 devices for Microbiological Research Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Microbiological Research Corp.'s devices?
Among its 14 most recently registered devices, Microbiological Research Corp. has devices listed in FDA 510(k) (14 devices).
What risk classes do Microbiological Research Corp.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Microbiological Research Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Microbiological Research Corp. in the registry?
The most recently registered devices listed for Microbiological Research Corp. include THE GOLDEN QUAD TEST (EBV), RUBELLA VIRUS SEROLOGICAL REAGENTS, CMV TEST and THE GOLDEN QUAD TEST (TOXO).