K-ASSAY® Cystatin C Control K100C-4M

GUDID 00816426020917

For use as a consistent test sample of known concentration for monitoring assay conditions for cystatin C.

KAMIYA BIOMEDICAL COMPANY, LLC

Plasma protein IVD, control
Primary Device ID00816426020917
NIH Device Record Keyb2e1ed8a-f6aa-4f58-95f8-5253fdc5b23e
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-ASSAY® Cystatin C Control
Version Model NumberK100C-4M
Catalog NumberK100C-4M
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816426020917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

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® Cystatin C Control]

00816426020917For use as a consistent test sample of known concentration for monitoring assay conditions for c
00816426020900For use as a consistent test sample of known concentration for monitoring assay conditions for c

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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