K-ASSAY® UIBC Reagent KAI-300

GUDID 00816426021396

For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.

KAMIYA BIOMEDICAL COMPANY, LLC

Unsaturated iron binding capacity (UIBC) IVD, reagent
Primary Device ID00816426021396
NIH Device Record Keyac573289-03c5-4091-8ed4-dca4f0ca45ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-ASSAY® UIBC Reagent
Version Model NumberKAI-300
Catalog NumberKAI-300
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816426021396 [Primary]

FDA Product Code

JMOFerrozine (Colorimetric) Iron Binding Capacity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-17
Device Publish Date2019-04-09

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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 Reagent2019-04-17For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.
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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