Universal Reagents, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 8
What Universal Reagents, Inc. makes
Universal Reagents, Inc. manufactures a range of factor deficient plasmas, including specific products for factors V, VII, VIII, IX, X, XI, and XII. These reagents are used in coagulation testing and laboratory diagnostics.
The company is based in the United States, and its portfolio of Class II medical devices is listed in the FDA 510(k) regulatory registry.
Catalogue
- 510(k) 510(k)
Factor Deficient Plasmas - Factor Xi (11) Ref K972286
510(k) 510(k)Universal Reagent Factor Viii Deficient Plasma Ref K970593
510(k) 510(k)Factor Deficient Plasmas - Factor Ix (9) Ref K972288
510(k) 510(k)Universal Reagent Factor X Deficient Plasma Ref K964459
510(k) 510(k)Universal Reagent Factor Vii Deficient Plasma Ref K970607
510(k) 510(k)Factor Deficient Plasma Ref K961929
510(k) 510(k)Universal Reagent Factor V Deficient Plasma Ref K964270
510(k) 510(k)
Frequently asked questions
How many devices does Universal Reagents, Inc. have in the registry?
The registry currently lists 8 devices for Universal Reagents, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Universal Reagents, Inc.'s devices?
Among its 8 most recently registered devices, Universal Reagents, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Universal Reagents, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Universal Reagents, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Universal Reagents, Inc. in the registry?
The most recently registered devices listed for Universal Reagents, Inc. include UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA, FACTOR DEFICIENT PLASMAS - FACTOR XI (11), UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA and FACTOR DEFICIENT PLASMAS - FACTOR IX (9).