Pb Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Pb Diagnostics, Inc. makes
Pb Diagnostics, Inc. manufactures serology test systems and controls for infectious disease diagnostics, including assays for toxoplasmosis, cytomegalovirus (CMV), and rubella antibodies. The OPUS(R) TOXO-G TEST SYSTEM detects toxoplasma antibodies, while the OPUS SEROLOGY CONTROLS provide calibration standards for serological testing. Additional offerings include the OPUS(R) ANTI CMV-M for CMV antibody detection and the OPUS RUBELLA TEST SYSTEM for rubella serology.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These systems are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the US. The manufacturer operates from the United States.
Catalogue
Opus(R) Toxo-G Test System Ref K921523
Regimes: 510(k) Registry: 510(k)Opus Serology Controls Ref K925703
Regimes: 510(k) Registry: 510(k)Opus(R) Anti Cmv-M Ref K913080
Regimes: 510(k) Registry: 510(k)Opus Rubella Test System Ref K915870
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pb Diagnostics, Inc. have in the registry?
The registry currently lists 4 devices for Pb Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pb Diagnostics, Inc.'s devices?
Among its 4 most recently registered devices, Pb Diagnostics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Pb Diagnostics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Pb 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 Pb Diagnostics, Inc. in the registry?
The most recently registered devices listed for Pb Diagnostics, Inc. include OPUS(R) TOXO-G TEST SYSTEM, OPUS SEROLOGY CONTROLS, OPUS(R) ANTI CMV-M and OPUS RUBELLA TEST SYSTEM.