Scripps-Miles, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Scripps-Miles, Inc. makes
Scripps-Miles, Inc. manufactures diagnostic test kits and reference control sera for immunology and rheumatology applications. These include kits for detecting antinuclear antibodies (ANA), rheumatoid factor, complement components (C3 and C4), and nephelometric antisera. The company also supplies control sera for reference use in laboratory testing.
The portfolio includes Class I and Class II devices, with products authorised via the FDA’s 510(k) pathway. These diagnostic tools are listed under US regulatory requirements and are intended for in vitro use in clinical laboratories.
Catalogue
Hep-2-Crithidia Luciliae Ana Test Kit Ref K811714
Regimes: 510(k) Registry: 510(k)Scrippsera Theumatoid Factor Refer. Cntl Ref K810221
Regimes: 510(k) Registry: 510(k)Scrippsera Complement Control Sera Ref K811433
Regimes: 510(k) Registry: 510(k)Scrippsystem C4 Rid Kit Ref K810502
Regimes: 510(k) Registry: 510(k)Scrippsystem C3 Rid Kit Ref K810501
Regimes: 510(k) Registry: 510(k)Scrippsystem Nephelometric Antisera Kit Ref K812328
Regimes: 510(k) Registry: 510(k)Scrippsera Ana Reference Control Sera Ref K810081
Regimes: 510(k) Registry: 510(k)Scrippsystem Immunoglobin Rid Kit Ref K812453
Regimes: 510(k) Registry: 510(k)Scrippsystem Rheumatoid Factor Latex Kit Ref K810141
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scripps-Miles, Inc. have in the registry?
The registry currently lists 9 devices for Scripps-Miles, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scripps-Miles, Inc.'s devices?
Among its 9 most recently registered devices, Scripps-Miles, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Scripps-Miles, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Scripps-Miles, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scripps-Miles, Inc. in the registry?
The most recently registered devices listed for Scripps-Miles, Inc. include HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT, SCRIPPSERA THEUMATOID FACTOR REFER. CNTL, SCRIPPSERA COMPLEMENT CONTROL SERA and SCRIPPSYSTEM C4 RID KIT.