K-ASSAY® Factor XIII Calibrator KAI-106C

GUDID 00816426020719

For the calibration of the K-ASSAY® Factor XIII assay.

KAMIYA BIOMEDICAL COMPANY, LLC

Coagulation factor XIII IVD, calibrator
Primary Device ID00816426020719
NIH Device Record Key7d7eb821-49c3-4c2a-ab12-f0c8cb3069b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-ASSAY® Factor XIII Calibrator
Version Model NumberKAI-106C
Catalog NumberKAI-106C
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816426020719 [Primary]

FDA Product Code

DBTFactor Xiii A, S, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

On-Brand Devices [K-ASSAY® Factor XIII Calibrator]

00816426020764For the calibration of the K-ASSAY® Factor XIII assay.
00816426020719For the calibration of the K-ASSAY® Factor XIII assay.

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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