Btc Diagnostics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Btc Diagnostics, Inc. makes
Btc Diagnostics, Inc. manufactures diagnostic tests for hormone detection, including enzyme immunoassays for urinary luteinizing hormone (LH), human chorionic gonadotropin (HCG), and qualitative detection assays. Their portfolio also includes lateral flow test strips (e.g., the HCG Accu-Stick) for point-of-care hormone screening.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II medical devices. Their assays are listed in the FDA’s 510(k) database, and the company operates from the United States.
Catalogue
Enzyme Immunoassay For Detection Horm Ref K841545
510(k) 510(k)Qualitative Enzyme Immunoassay-Detect Ref K832905
510(k) 510(k)Btc Urine Lcg Assay Ref K831125
510(k) 510(k)Btc Urine Lh Assay Ref K833710
510(k) 510(k)Hcg Accu-Stick Ref K831604
510(k) 510(k)
Frequently asked questions
How many devices does Btc Diagnostics, Inc. have in the registry?
The registry currently lists 5 devices for Btc Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Btc Diagnostics, Inc.'s devices?
Among its 5 most recently registered devices, Btc Diagnostics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Btc Diagnostics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Btc 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 Btc Diagnostics, Inc. in the registry?
The most recently registered devices listed for Btc Diagnostics, Inc. include ENZYME IMMUNOASSAY FOR DETECTION HORM, QUALITATIVE ENZYME IMMUNOASSAY-DETECT, BTC URINE LCG ASSAY and BTC URINE LH ASSAY.