Strategic Diagnostics, Inc.
Country not established
- Devices
- 1
What Strategic Diagnostics, Inc. makes
Strategic Diagnostics, Inc. produces the MACRALP(A) Enzyme Immunoassay Kit, a diagnostic test designed for measuring alpha-1 antitrypsin levels in serum or plasma samples. This assay is intended for use in clinical laboratories to aid in the diagnosis and monitoring of alpha-1 antitrypsin deficiency, a genetic condition linked to lung and liver diseases.
The MACRALP(A) Enzyme Immunoassay Kit is classified as a Class I medical device under FDA regulations and has undergone the 510(k) clearance process. The company is headquartered in the United States, where its products are registered and available for clinical use.
Catalogue
Macralp(A) Enzyme Immunoassay Kit Ref K971157
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Strategic Diagnostics, Inc. have in the registry?
The registry currently lists 1 device for Strategic Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Strategic Diagnostics, Inc.'s devices?
Among its 1 most recently registered device, Strategic Diagnostics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Strategic Diagnostics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Strategic Diagnostics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Strategic Diagnostics, Inc. in the registry?
The most recently registered devices listed for Strategic Diagnostics, Inc. include MACRALP(A) ENZYME IMMUNOASSAY KIT.