Applied Dna Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Applied Dna Technologies, Inc. makes
Applied Dna Technologies, Inc. manufactures diagnostic test panels and cassettes for detecting drugs of abuse (DOA) in single and multi-strip formats, as well as pregnancy tests for human chorionic gonadotropin (HCG) in urine and serum using cassette and dipstick designs.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records in the U.S. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Bionexia Hcg Pregnancy Serum/Urine Cassette And Dipstick Tests, Models 08-Hcgc And 02-Hcgc Ref K071030
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Applied Dna Technologies, Inc. have in the registry?
The registry currently lists 4 devices for Applied Dna Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Applied Dna Technologies, Inc.'s devices?
Among its 4 most recently registered devices, Applied Dna Technologies, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Applied Dna Technologies, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Applied Dna Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Applied Dna Technologies, Inc. in the registry?
The most recently registered devices listed for Applied Dna Technologies, Inc. include ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS, BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG, BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC and BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,.