Access Free T4 33880

GUDID 15099590225834

The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human

Beckman Coulter, Inc.

Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590225834
NIH Device Record Keyf596726d-84cc-48c4-b66c-b859827f5155
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Free T4
Version Model Number33880
Catalog Number33880
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
GS115099590225834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CECRadioimmunoassay, Free Thyroxine

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

On-Brand Devices [Access Free T4]

15099590225834The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quanti
15099590780982The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quanti

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