Protos Laboratories
Country not established
- Devices
- 6
What Protos Laboratories makes
Protos Laboratories produces polyclonal antibodies for diagnostic use, including goat-derived antisera targeting human immunoglobulins (IgM, IgG gamma chain, lambda chain), C-reactive protein, alpha-1-antitrypsin, and complement component C4. These reagents are designed for immunoassays and related laboratory testing applications.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where they are subject to premarket notification requirements.
Catalogue
Goat Anti-Human Igm Ref K802177
Regimes: 510(k) Registry: 510(k)Goat Anti-Human Igg Gamma Chain Specific Ref K802257
Regimes: 510(k) Registry: 510(k)Goat Anti-Human C-Reactive Protein Ref K791560
Regimes: 510(k) Registry: 510(k)Goat Anti-Human Alpha-1-Antitrypsin Ref K791605
Regimes: 510(k) Registry: 510(k)Goar Anti-Human Lamboda Chain Ref K791115
Regimes: 510(k) Registry: 510(k)Goat Anti-Human Complement C4 Ref K802196
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Protos Laboratories have in the registry?
The registry currently lists 6 devices for Protos Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Protos Laboratories's devices?
Among its 6 most recently registered devices, Protos Laboratories has devices listed in FDA 510(k) (6 devices).
What risk classes do Protos Laboratories's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Protos Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Protos Laboratories in the registry?
The most recently registered devices listed for Protos Laboratories include GOAT ANTI-HUMAN IGM, GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC, GOAT ANTI-HUMAN C-REACTIVE PROTEIN and GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN.