Skyland Scientific Services, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Skyland Scientific Services, Inc. makes
Skyland Scientific Services, Inc. manufactures biological indicators used for validating sterilization processes, including 48-hour SporStrip indicators and standard SporStrip formats. These devices are designed to detect microbial contamination in sterilization cycles, ensuring process efficacy.
The company’s products are classified as Class II devices under FDA regulations and are listed via 510(k) clearance. The portfolio is regulated in the United States, where the manufacturer is based.
Catalogue
Evidence Biological Indicator Ref K910417
Regimes: 510(k) Registry: 510(k)48 Hour Biological Indicators Sporstrip Ref K841709
Regimes: 510(k) Registry: 510(k)Sporstrip Ref K841583
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Skyland Scientific Services, Inc. have in the registry?
The registry currently lists 3 devices for Skyland Scientific Services, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Skyland Scientific Services, Inc.'s devices?
Among its 3 most recently registered devices, Skyland Scientific Services, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Skyland Scientific Services, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Skyland Scientific Services, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Skyland Scientific Services, Inc. in the registry?
The most recently registered devices listed for Skyland Scientific Services, Inc. include EVIDENCE BIOLOGICAL INDICATOR, 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP and SPORSTRIP.