xTAG Cystic Fibrosis 39 Kit v2
K-Number: K163347 · 2016-12-15
Device Summary
Frequently Asked Questions
What is the xTAG Cystic Fibrosis 39 Kit v2?
xTAG Cystic Fibrosis 39 Kit v2 is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K163347.
When did xTAG Cystic Fibrosis 39 Kit v2 receive FDA 510(k) clearance?
xTAG Cystic Fibrosis 39 Kit v2 received FDA 510(k) clearance on 2016-12-15, under 510(k) number K163347.
Who is the listed applicant for xTAG Cystic Fibrosis 39 Kit v2?
The FDA 510(k) record lists Luminex Molecular Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for xTAG Cystic Fibrosis 39 Kit v2?
The FDA product code for xTAG Cystic Fibrosis 39 Kit v2 is NUA.
Other records listing Luminex Molecular Diagnostics, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: NUA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.