AccessGUDID - DEVICE: K-ASSAY® Apo AI/B Calibrator (00816426020542)

GUDID

Device Identifier (DI) Information

Brand Name: K-ASSAY® Apo AI/B Calibrator
Version or Model: KAI-008C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KAI-008C
Company Name: KAMIYA BIOMEDICAL COMPANY, LLC

Primary DI Number: 00816426020542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 197934250 *Terms of Use

Device Description: For the calibration of the K-ASSAY® Apo AI and Apo B assays.

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?
53356	Multiple lipid analyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIX	Calibrator, Multi-Analyte Mixture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993606	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
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: 8b6b9b9c-9163-4477-b09c-9dffb94eedab
Public Version Date: December 08, 2022
Public Version Number: 4
DI Record Publish Date: September 16, 2016