K-ASSAY® Apo AI / B Control K310C-2M

GUDID 00816426021631

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

KAMIYA BIOMEDICAL COMPANY, LLC

Multiple apolipoprotein IVD, control
Primary Device ID00816426021631
NIH Device Record Key37da4021-f434-4c9a-bb8d-0a99bb3356ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-ASSAY® Apo AI / B Control
Version Model NumberK310C-2M
Catalog NumberK310C-2M
Company DUNS197934250
Company NameKAMIYA BIOMEDICAL COMPANY, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com
Phone206-575-8068
Emaildiagnostics@k-assay.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816426021631 [Primary]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-05
Device Publish Date2020-12-28

On-Brand Devices [K-ASSAY® Apo AI / B Control]

00816426021648For use as a consistent test sample of known concentration for monitoring assay conditions for A
00816426021631For use as a consistent test sample of known concentration for monitoring assay conditions for A

Trademark Results [K-ASSAY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
K-ASSAY
K-ASSAY
75060842 2045784 Live/Registered
KAMIYA BIOMEDICAL COMPANY, LLC
1996-02-22
K-ASSAY
K-ASSAY
74707766 2011686 Live/Registered
KAMIYA BIOMEDICAL COMPANY, LLC
1995-07-28

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