Johnson & Johnson Clinical Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 33
What Johnson & Johnson Clinical Diagnostics, Inc. makes
The company manufactures in vitro diagnostic reagents, calibrators, and slides for clinical chemistry and immunodiagnostics, including kits for measuring cardiac markers (CK-MB), hormones (LH, prolactin, free T4), cholesterol (LDL), calcium, C-reactive protein, urea nitrogen, and ferritin. Products like the VITROS and EKTACHEM series are designed for automated laboratory analysis to support diagnostic testing for conditions such as cardiovascular disease, thyroid dysfunction, and metabolic disorders.
These devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded via 510(k) pathways. The manufacturer is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Search and filter all 33 devicesFrequently asked questions
How many devices does Johnson & Johnson Clinical Diagnostics, Inc. have in the registry?
The registry currently lists 33 devices for Johnson & Johnson Clinical Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Johnson & Johnson Clinical Diagnostics, Inc.'s devices?
Among its 33 most recently registered devices, Johnson & Johnson Clinical Diagnostics, Inc. has devices listed in FDA 510(k) (33 devices).
What risk classes do Johnson & Johnson Clinical Diagnostics, Inc.'s devices fall under?
Among its 33 most recently registered devices, the classes recorded for Johnson & Johnson Clinical Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Johnson & Johnson Clinical Diagnostics, Inc. in the registry?
The most recently registered devices listed for Johnson & Johnson Clinical Diagnostics, Inc. include VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300), VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55), EKTACHEM DT LDL CHOLESTEROL KIT and VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS.