Product code NUA— Immunology
TAG-IT CYSTIC FIBROSIS KIT
- Classification name
- System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
- Device class
- Class 2
- Regulation
- 21 CFR 866.5900
- Advisory panel
- Immunology
- Total cleared
- 12
- First cleared
- Most recent
FDA classification definition
“The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.”
Market context for product code NUA
FDA has cleared devices under product code NUA between 2005 and 2016, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2016
- 2009
- 2008
- 2007
- 2006
- 2005
Top applicants under product code NUA
Recent clearances under product code NUA
- K163336 — xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
- K163347 — xTAG Cystic Fibrosis 39 Kit v2
- K083845 — XTAG CF60 KIT V2
- K083846 — XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
- K083294 — VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
- K090901 — ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
- K063787 — INPLEX CF MOLECULAR TEST
- K062028 — CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
- K060627 — TAG-IT CYSTIC FIBROSIS KIT
- K060543 — ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
- K051435 — ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
- DEN050004 — TAG-IT CYSTIC FIBROSIS KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.