AccessGUDID - DEVICE: Immuno Control Set (08058056680204)

GUDID

Device Identifier (DI) Information

Brand Name: Immuno Control Set
Version or Model: 11211A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11211A
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056680204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: Immuno Control Set is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For professional use only. For In Vitro diagnostic use.

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):	Yes
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?
30506	Plasma protein IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: Store between 2 and 8 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 4 Milliliter

Device Record Status

Public Device Record Key: e84862e8-f8d8-4165-898c-d0af2cb448b7
Public Version Date: February 25, 2020
Public Version Number: 2
DI Record Publish Date: November 15, 2018