Atlantic Antibodies
Country not established
- Devices
- 18
What Atlantic Antibodies makes
Atlantic Antibodies manufactures antibody reagent sets and test systems for clinical diagnostics, including products for immunology assays (IgA, IgG, IgM, C3, C4, AAT) and specialized biomarkers like microalbumin, apolipoproteins (A-I/B), and C-reactive protein (CRP). These reagents are designed for turbidimetric (TRF) and homogeneous particle turbidimetric (HPT) immunoassays, as well as direct test systems for point-of-care or laboratory use.
The company’s portfolio includes devices classified as Class I (general controls) and Class II (special controls), all of which are subject to FDA 510(k) clearance. Products are listed under the FDA 510(k) registry and are intended for use in the United States.
Catalogue
Search and filter all 18 devicesFrequently asked questions
How many devices does Atlantic Antibodies have in the registry?
The registry currently lists 18 devices for Atlantic Antibodies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Atlantic Antibodies's devices?
Among its 18 most recently registered devices, Atlantic Antibodies has devices listed in FDA 510(k) (18 devices).
What risk classes do Atlantic Antibodies's devices fall under?
Among its 18 most recently registered devices, the classes recorded for Atlantic Antibodies's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Atlantic Antibodies in the registry?
The most recently registered devices listed for Atlantic Antibodies include SPQ(TM) ANTIBODY REAGENT SET II FOR TRF, SPQ(TM) ANTIBODY REAGENT SET II FOR HPT, SPQ(TM) TEST SYSTEM FOR MICROALBUMIN and SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL.