NUA

Product Code: NUA

Products Classified as NUA

4920

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System.

Total Product Life Cycle (TPLC) Devices

4920

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System.

Pre-market Notifications for NUA

K163347	XTAG Cystic Fibrosis 39 Kit V2	Luminex Molecular Diagnostics, Inc.
K163336	XTAG Cystic Fibrosis 60 Kit V2, XTAG Data Analysis Software (TDAS) CFTR	Luminex Molecular Diagnostics, Inc.
K090901	ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8	OSMETECH MOLECULAR DIAGNOSTICS
K083846	XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267	LUMINEX MOLECULAR DIAGNOSTICS, INC.
K083845	XTAG CF60 KIT V2	LUMINEX MOLECULAR DIAGNOSTICS, INC.
K083294	VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST	NANOSPHERE, INC
K063787	INPLEX CF MOLECULAR TEST	THIRD WAVE TECHNOLOGIES, INC.
K062028	CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01	CELERA DIAGNOSTICS
K060627	TAG-IT CYSTIC FIBROSIS KIT	TM BIOSCIENCE CORPORATION
K060543	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800	CLINICAL MICRO SENSORS, INC.
K051435	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800	CLINICAL MICRO SENSORS

Global Unique Device Identification Database

• 00840487100141: System, cystic fibrosis transmembrane conductance regulator, gene mutation detection
• 00840487100479: System, cystic fibrosis transmembrane conductance regulator, gene mutation detection
• 00840487100455: System, cystic fibrosis transmembrane conductance regulator, gene mutation detection

Maude Adverse Events

*CYSTIC FIBROSIS CARD REAGENT	HOLOGIC, INC	2013-08-14
*CYSTIC FIBROSIS CARD REAGENT	HOLOGIC, INC	2013-08-14
*CYSTIC FIBROSIS CARD REAGENT	HOLOGIC, INC	2013-08-14
*CYSTIC FIBROSIS CARD REAGENT	HOLOGIC, INC	2013-08-14
*CYSTIC FIBROSIS CARD REAGENT	HOLOGIC, INC	2013-08-14
*CYSTIC FIBROSIS CARD REAGENT	HOLOGIC, INC	2013-08-14
*CYSTIC FIBROSIS CARD REAGENT	HOLOGIC, INC	2013-08-14
*CYSTIC FIBROSIS CARD REAGENT	HOLOGIC, INC	2013-08-14
*CYSTIC FIBROSIS CARD REAGENT	HOLOGIC, INC	2013-08-14
THIRD WAVE CFTR INPLEX REAGENTS	THIRD WAVE TECHNOLOGIES, INC.	2006-05-10
THIRD WAVE CFTR INPLEX AMPLIFICATION PRIMERS	THIRD WAVE TECHNOLOGIES, INC.	2006-05-10
THIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS	THIRD WAVE TECHNOLOGIES, INC.	2006-05-10
THIRD WAVE INVADER REAGENTS	THIRD WAVE TECHNOLOGIES, INC.	2006-03-20