Meloy Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Meloy Laboratories, Inc. makes
Meloy Laboratories, Inc. manufactures in vitro diagnostic test kits and systems for detecting autoantibodies and immune markers, including anti-native deoxyribonucleic acid antibody tests, anti-nuclear antibody (ANA) assays using HEP-2 cells or mouse liver substrate, anti-mitochondrial antibody tests, SS-A(RO) and SS-B(LA) antibody assays, and human IgG-albumin test kits. The company also produces immunospot and immunostat test systems for thyroid-stimulating hormone (TSH) and monoclonal factor VIII detection, as well as total hemolytic complement test kits.
These devices are classified as Class II medical devices and are listed in the FDA’s 510(k) premarket notification database. Meloy Laboratories, Inc. is based in the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Meloy Laboratories, Inc. have in the registry?
The registry currently lists 15 devices for Meloy Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Meloy Laboratories, Inc.'s devices?
Among its 15 most recently registered devices, Meloy Laboratories, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Meloy Laboratories, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Meloy Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Meloy Laboratories, Inc. in the registry?
The most recently registered devices listed for Meloy Laboratories, Inc. include ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI, ANTI-NUCLEAR ANTIBODY TEST, IMMUNOSPOT TSH TEST and MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL.