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FDA 510(k)

xTAG Cystic Fibrosis 39 Kit v2

K-Number: K163347 · 2016-12-15

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2016-12-15
Product CodeNUA
Advisory CommitteeIM
DecisionUnknown

Device Summary

xTAG Cystic Fibrosis 39 Kit v2 is a medical device manufactured by Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-12-15 under approval number K163347. The device is classified under product code NUA. It was reviewed by the IM advisory panel. FDA Decision: Unknown.

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. It is manufactured by Luminex Molecular Diagnostics, Inc.. The 510(k) number is K163347.

When was xTAG Cystic Fibrosis 39 Kit v2 approved by the FDA?

xTAG Cystic Fibrosis 39 Kit v2 received FDA 510(k) clearance on 2016-12-15, under approval number K163347.

What company makes xTAG Cystic Fibrosis 39 Kit v2?

xTAG Cystic Fibrosis 39 Kit v2 is manufactured by Luminex Molecular Diagnostics, Inc..

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.

Related Clinical Trials

NCT03357562 MR Imaging of Lung in the Follow-up Assessment of Cystic Fibrosis COMPLETED NCT06691893 Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients RECRUITING NCT05783869 Study of Bronchiectasis and Associated Cardiovascular Comorbidities RECRUITING NCT06808880 EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND) RECRUITING NCT05531630 Xylitol vs Saline Nasal Irrigations in CF-CRS ENROLLING_BY_INVITATION NCT06311292 Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis COMPLETED

Other Devices by Luminex Molecular Diagnostics, Inc.

K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR K170492xTAG CYP2D6 Kit v3 K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software K191161xTAG Gastrointestinal Pathogen Panel (GPP)

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Related Devices (Code: NUA)

K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRLuminex Molecular Diagnostics, Inc.

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.

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