K-ASSAY® Lp(a) Reagent KAI-044

GUDID 00816426020245

For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.

KAMIYA BIOMEDICAL COMPANY, LLC

Lipoprotein A IVD, reagent
Primary Device ID00816426020245
NIH Device Record Key4dbd2153-7307-447a-b800-dab18730557c
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-ASSAY® Lp(a) Reagent
Version Model NumberKAI-044
Catalog NumberKAI-044
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
GS100816426020245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DFCLipoprotein, Low-Density, Antigen, Antiserum, Control

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

Devices Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC

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00816426021679 - K-ASSAY® hsCRP Control2021-03-09 For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP).
00816426021631 - K-ASSAY® Apo AI / B Control2021-01-05 For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
00816426021648 - K-ASSAY® Apo AI / B Control2021-01-05 For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
00816426020894 - K-ASSAY® Plasma Control2019-12-27 For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
00816426021129 - K-ASSAY® Factor XIII Control2019-12-27 For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.
00816426021396 - K-ASSAY® UIBC Reagent2019-04-17 For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.
00816426021402 - K-ASSAY® UIBC Reagent (L)2019-04-17 For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.

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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