Apple Diagnostic Products
Country not established
- Devices
- 7
What Apple Diagnostic Products makes
Apple Diagnostic Products manufactures in vitro diagnostic tests for detecting antibodies and antigens in blood and other specimens. Their portfolio includes immunofluorescence assays (IFA) for autoimmune markers like ANA, tests for Chlamydia trachomatis, and enzyme-linked assays for Toxoplasma gondii antibodies. These tests are designed for clinical laboratories to aid in diagnosing infectious diseases and autoimmune conditions.
The company’s diagnostic tests are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. Their products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Adp Ndna Ifa Test Ref K842707
Regimes: 510(k) Registry: 510(k)Adp Ana Ifa Test Ref K842183
Regimes: 510(k) Registry: 510(k)Adp Ana Applezyme Ref K843745
Regimes: 510(k) Registry: 510(k)Adp Ifa Test For Chlamydiae Trachomatis Ref K834242
Regimes: 510(k) Registry: 510(k)Ana Applelisa Ref K834241
Regimes: 510(k) Registry: 510(k)Adpifa Test For Antibodies To Toxoplasma Gondii Ref K844287
Regimes: 510(k) Registry: 510(k)Applelisa Chlamydia Trachomatis Anti Ref K843120
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Apple Diagnostic Products have in the registry?
The registry currently lists 7 devices for Apple Diagnostic Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apple Diagnostic Products's devices?
Among its 7 most recently registered devices, Apple Diagnostic Products has devices listed in FDA 510(k) (7 devices).
What risk classes do Apple Diagnostic Products's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Apple Diagnostic Products's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Apple Diagnostic Products in the registry?
The most recently registered devices listed for Apple Diagnostic Products include ADP NDNA IFA TEST, ADP ANA IFA TEST, ADP ANA APPLEZYME and ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS.