Duns Number:172874245
Device Description: This independent CF control is intended for in vitro diagnostic use to monitor the entire This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Catalog Number
G106ac
Brand Name
INTROL CF Panel I Control
Version/Model Number
v.02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083171
Product Code
NZB
Product Code Name
Quality Control Material, Genetics, Dna
Public Device Record Key
658d32f2-0d9a-426b-b834-073300a3cd2e
Public Version Date
January 01, 2020
Public Version Number
1
DI Record Publish Date
December 24, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |