Shared Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Shared Systems, Inc. makes
Shared Systems, Inc. manufactures in vitro diagnostic (IVD) test systems for detecting specific antibodies and pathogens, including latex agglutination and enzyme immunoassay (EIA) assays for C-reactive protein, rheumatoid factor, *Mycoplasma pneumoniae* antibodies, and *E. coli* O157.
These products are classified as Class I and Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Chromalex C-Reactive Protein Latex Test System Ref K955042
Regimes: 510(k) Registry: 510(k)Chromalex Rheumatoid Factor Latex Test System Ref K953261
Regimes: 510(k) Registry: 510(k)Mycoplasma Pneumoniae Antibody Eia Test System Ref K920212
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Shared Systems, Inc. have in the registry?
The registry currently lists 5 devices for Shared Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shared Systems, Inc.'s devices?
Among its 5 most recently registered devices, Shared Systems, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Shared Systems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Shared Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shared Systems, Inc. in the registry?
The most recently registered devices listed for Shared Systems, Inc. include CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM, CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM, MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM and CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800.