Indilab, Inc.
United StatesFDA applicant, unverified FDA FEI 1450962
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Indilab, Inc. makes
Indilab, Inc. manufactures sterilization process indicators, including the INDISTRIP and INDISTRIP GREEN product lines.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
- Registry: GUDID
Indistrip Green Ref K110369
Regimes: 510(k) Registry: 510(k)Indistrip (Sterilization Process Indicator) Ref K875193
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1450962
- DUNS number
- 187129721
- Address
- 10367 FRANKLIN AVE., FRANKLIN PARK, IL, 60131
- [email protected]
- Phone
- 847-928-1050
Frequently asked questions
How many devices does Indilab, Inc. have in the registry?
The registry currently lists 3 devices for Indilab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Indilab, Inc.'s devices?
Among its 3 most recently registered devices, Indilab, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Indilab, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Indilab, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Indilab, Inc. in the registry?
The most recently registered devices listed for Indilab, Inc. include IND400S, INDISTRIP GREEN and INDISTRIP (STERILIZATION PROCESS INDICATOR).