Boots-Celltech Diagnostics, Inc.
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- Devices
- 20
What Boots-Celltech Diagnostics, Inc. makes
Boots-Celltech Diagnostics, Inc. manufactures immunoradiometric assays (IRMA) for hormone detection, including human growth hormone (HGH), prolactin (HPR), thyroid-stimulating hormone (TSH), and luteinizing hormone (LH). The company also produces diagnostic tests for infectious diseases, such as chlamydia, respiratory syncytial virus (RSV), and herpes simplex virus (HSV), including typing assays and modified versions of certain tests. Additional products include a dual-analyte test for ovarian function and modified documentation for use with specific diagnostic platforms.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. These products are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Boots-Celltech Diagnostics, Inc. have in the registry?
The registry currently lists 20 devices for Boots-Celltech Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boots-Celltech Diagnostics, Inc.'s devices?
Among its 20 most recently registered devices, Boots-Celltech Diagnostics, Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Boots-Celltech Diagnostics, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Boots-Celltech 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 Boots-Celltech Diagnostics, Inc. in the registry?
The most recently registered devices listed for Boots-Celltech Diagnostics, Inc. include SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA, MODIFIED IMAGEN(TM) CHLAMYDIA TEST, SUCROSEP HUMAN PROLACTIN (HPR) IRMA and SUCROSEP THYROID STIMULATING HORMONE.