Biotech Atlantic, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Biotech Atlantic, Inc. makes
Biotech Atlantic, Inc. manufactures home-based pregnancy testing devices, including digital and strip formats for detecting human chorionic gonadotropin (hCG) in urine. Products include single-use test sticks, midstream collection devices, and combo tests designed for at-home use.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Unimark Home Pregnancy Test Device Ref K032992
510(k) 510(k)Unimark Midstream Pregnancy Test Stick Ref K960174
510(k) 510(k)Unimark Hcg Combo Pregnancy Test Ref K013194
510(k) 510(k)Unistep Hcg Pregnancy Test Strip Ref K941090
510(k) 510(k)
Frequently asked questions
How many devices does Biotech Atlantic, Inc. have in the registry?
The registry currently lists 4 devices for Biotech Atlantic, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotech Atlantic, Inc.'s devices?
Among its 4 most recently registered devices, Biotech Atlantic, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Biotech Atlantic, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Biotech Atlantic, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotech Atlantic, Inc. in the registry?
The most recently registered devices listed for Biotech Atlantic, Inc. include UNIMARK HOME PREGNANCY TEST DEVICE, UNIMARK MIDSTREAM PREGNANCY TEST STICK, UNIMARK HCG COMBO PREGNANCY TEST and UNISTEP HCG PREGNANCY TEST STRIP.