AccessGUDID - DEVICE: INTROL CF Panel I Control (00852720008008)

GUDID

Device Identifier (DI) Information

Brand Name: INTROL CF Panel I Control
Version or Model: v.02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G106ac-1
Company Name: Mmqci

Primary DI Number: 00852720008008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 172874245 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59364	Cystic fibrosis IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZB	Quality Control Material, Genetics, Dna

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083171	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Opened material returned to the refrigerator (2° – 8°C) shortly after use is stable for thirty (30) days from the date of opening.
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5034854f-ef3a-4925-ba0b-41f8d1f8cafb
Public Version Date: December 13, 2019
Public Version Number: 1
DI Record Publish Date: December 05, 2019