Access Ferritin Calibrators 33025

GUDID 15099590575045

The Access Ferritin Calibrators are intended to calibrate the Access Ferritin assay for the quantitative determination of ferritin levels in human ser

Beckman Coulter, Inc.

Ferritin IVD, kit, enzyme immunoassay (EIA) Ferritin IVD, kit, enzyme immunoassay (EIA)
Primary Device ID15099590575045
NIH Device Record Keya95eb057-24a0-4484-86f1-09b22fec6597
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Ferritin Calibrators
Version Model Number33025
Catalog Number33025
Company DUNS008254708
Company NameBeckman Coulter, Inc.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590575045 [Primary]

FDA Product Code

JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-04-09
Device Publish Date2016-09-09

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