AccessGUDID - DEVICE: K-ASSAY® Apo AI / B Control (00816426021631)

GUDID

Device Identifier (DI) Information

Brand Name: K-ASSAY® Apo AI / B Control
Version or Model: K310C-2M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K310C-2M
Company Name: KAMIYA BIOMEDICAL COMPANY, LLC

Primary DI Number: 00816426021631
Issuing Agency: GS1
Commercial Distribution End Date: August 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 197934250 *Terms of Use

Device Description: For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.

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?
43708	Multiple apolipoprotein IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple apolipoprotein lipid analytes 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
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: 37da4021-f434-4c9a-bb8d-0a99bb3356ac
Public Version Date: August 17, 2022
Public Version Number: 2
DI Record Publish Date: December 28, 2020