Cirrus Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Cirrus Diagnostics, Inc. makes
Cirrus Diagnostics, Inc. manufactures automated immunoassay analyzers and a variety of diagnostic reagent test packs. These products include assays for measuring hormones, cardiac markers, and inflammatory proteins such as T3, T4, FSH, HCG, Digoxin, and CRP.
The company is based in the United States and maintains a portfolio of Class I and Class II medical devices. These products are listed in the FDA 510(k) regulatory registry.
Catalogue
Immulite (Tm) Automated Immunoassay Analyzer Ref K905215
Regimes: 510(k) Registry: 510(k)Immulite(Tm) T-Uptake Ref K910677
Regimes: 510(k) Registry: 510(k)Crp Lipid Reagent Test Pack Ref K905648
Regimes: 510(k) Registry: 510(k)Immulite (Tm) Total T3 Ref K905214
Regimes: 510(k) Registry: 510(k)Immulite(Tm) Total T4 Ref K910261
Regimes: 510(k) Registry: 510(k)Immulite Digoxin Ref K914833
Regimes: 510(k) Registry: 510(k)Immulite(R) Fsh Ref K921704
Regimes: 510(k) Registry: 510(k)Immulite Hlh Ref K920411
Regimes: 510(k) Registry: 510(k)Immulite Hs-Tsh Ref K905769
Regimes: 510(k) Registry: 510(k)Immulite(Tm) Hcg Ref K911796
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cirrus Diagnostics, Inc. have in the registry?
The registry currently lists 10 devices for Cirrus Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cirrus Diagnostics, Inc.'s devices?
Among its 10 most recently registered devices, Cirrus Diagnostics, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Cirrus Diagnostics, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Cirrus Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cirrus Diagnostics, Inc. in the registry?
The most recently registered devices listed for Cirrus Diagnostics, Inc. include IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER, IMMULITE(TM) T-UPTAKE, CRP LIPID REAGENT TEST PACK and IMMULITE (TM) TOTAL T3.