Advanced Biomedical Methods, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 21
What Advanced Biomedical Methods, Inc. makes
Advanced Biomedical Methods, Inc. manufactures in vitro diagnostic reagents and tests for laboratory demand analyzers, including glucose monitoring (GLUC OPAP), blood urea nitrogen (S-UREA-N), liver function markers (LDH, SGOT/ALT), and lipid profiles (CHOLOPAP-HDL). Additional offerings include ion-selective electrode (ISE) reagents, magnesium and calcium assays, total protein and albumin reagents, and specialized tests like serum iron and salicylate measurements.
The company’s products are classified under FDA’s Class I and Class II categories, with most submissions recorded via the 510(k) pathway. These diagnostics are listed in the FDA’s regulatory database and comply with U.S. in vitro diagnostic device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 21 devicesFrequently asked questions
How many devices does Advanced Biomedical Methods, Inc. have in the registry?
The registry currently lists 21 devices for Advanced Biomedical Methods, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Biomedical Methods, Inc.'s devices?
Among its 21 most recently registered devices, Advanced Biomedical Methods, Inc. has devices listed in FDA 510(k) (21 devices).
What risk classes do Advanced Biomedical Methods, Inc.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Advanced Biomedical Methods, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Biomedical Methods, Inc. in the registry?
The most recently registered devices listed for Advanced Biomedical Methods, Inc. include GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE, MAGNESIUM REAGENT FOR DEMAND ANALYZER, LDH REAGENT FOR DEMAND ANALYZER and S-UREA-N, IN VITRO DIAG FOR BUN.