Murex Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Murex Corp. makes
Murex Corp. manufactures in vitro diagnostic (IVD) test kits for detecting specific antigens and antibodies in urine and serum samples. Their products include assays for human chorionic gonadotropin (HCG), Group A Streptococcus, toxoplasmosis (Toxo), rubella, and related reference materials. These tests are designed for clinical laboratory use to aid in diagnostic evaluations.
The company’s portfolio consists of Class I and Class II in vitro diagnostic devices, regulated under the FDA’s 510(k) clearance process. These products are intended for use in the United States and are listed in the FDA’s 510(k) database. The company is headquartered in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Murex Suds Group A Strep Ref K860576
Regimes: 510(k) Registry: 510(k)Murex Suds Toxo Ref K861458
Regimes: 510(k) Registry: 510(k)Murex (Tm), Suds (Tm), Hcg Assay Ref K860451
Regimes: 510(k) Registry: 510(k)Murex Suds Rubella Ref K861282
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Murex Corp. have in the registry?
The registry currently lists 5 devices for Murex Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Murex Corp.'s devices?
Among its 5 most recently registered devices, Murex Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Murex Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Murex Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Murex Corp. in the registry?
The most recently registered devices listed for Murex Corp. include SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM, MUREX SUDS GROUP A STREP, MUREX SUDS TOXO and MUREX (TM), SUDS (TM), HCG ASSAY.