K-ASSAY® Liquid ITA Control K49C-2M

GUDID 00816426020818

For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.

KAMIYA BIOMEDICAL COMPANY, LLC

Plasma protein IVD, control
Primary Device ID00816426020818
NIH Device Record Key1974fc4c-ec99-4076-b2ae-0a3812d23765
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-ASSAY® Liquid ITA Control
Version Model NumberK49C-2M
Catalog NumberK49C-2M
Company DUNS197934250
Company NameKAMIYA BIOMEDICAL COMPANY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816426020818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [K-ASSAY® Liquid ITA Control]

00816426020825For use as a consistent test sample of known concentration for monitoring assay conditions for t
00816426020818For use as a consistent test sample of known concentration for monitoring assay conditions for t

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.