K-ASSAY® Apo AI / B Control - For use as a consistent test sample of known - KAMIYA BIOMEDICAL COMPANY, LLC

Duns Number:197934250

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

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More Product Details

Catalog Number

K310C-2M

Brand Name

K-ASSAY® Apo AI / B Control

Version/Model Number

K310C-2M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 16, 2022

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KAMIYA BIOMEDICAL COMPANY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 66