Applications Lab
Country not established
- Devices
- 10
What Applications Lab makes
Applications Lab manufactures single-use SPQ test systems for quantifying specific proteins in serum or plasma, including complement proteins (C3, C4), immunoglobulins (IgA, IgG, IgM), haptoglobin, C-reactive protein, alpha-2 macroglobulin, alpha-1 antitrypsin, and transferrin. These systems are designed for laboratory use in clinical diagnostics to measure protein levels for patient monitoring or diagnostic evaluation.
The company’s portfolio consists of Class II devices, each authorised via the FDA’s 510(k) pathway. These systems are listed under the FDA’s regulatory framework and are intended for use in the United States. No additional registries or classifications are specified.
Catalogue
Spq Test System For Complement C4 Ref K850585
Regimes: 510(k) Registry: 510(k)Spq Test System For Immunoglobulin A Ref K850582
Regimes: 510(k) Registry: 510(k)Spq Test System For Immunoglobulin M Ref K850586
Regimes: 510(k) Registry: 510(k)Spq Test System For Haptoglobin Ref K850584
Regimes: 510(k) Registry: 510(k)Spq Test System For C-Reactive Protein Ref K850590
Regimes: 510(k) Registry: 510(k)Spq Test System For Alpha(2) Macroglobulin Ref K850603
Regimes: 510(k) Registry: 510(k)Spq Test System For Complement C3 Ref K850588
Regimes: 510(k) Registry: 510(k)Spq Test System For Alpha, - Antitrypsin Ref K850587
Regimes: 510(k) Registry: 510(k)Spq Test System For Transferrin Ref K850589
Regimes: 510(k) Registry: 510(k)Spq Test System For Immunoglobulin G Ref K850583
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Applications Lab have in the registry?
The registry currently lists 10 devices for Applications Lab. Devices recorded under merged duplicate company entries are counted once.
Which registries list Applications Lab's devices?
Among its 10 most recently registered devices, Applications Lab has devices listed in FDA 510(k) (10 devices).
What risk classes do Applications Lab's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Applications Lab's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Applications Lab in the registry?
The most recently registered devices listed for Applications Lab include SPQ TEST SYSTEM FOR COMPLEMENT C4, SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A, SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M and SPQ TEST SYSTEM FOR HAPTOGLOBIN.