Access Free T4 C76421

GUDID 15099590780982

The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) for the diagnosis and treatment of thyroid diseases using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590780982
NIH Device Record Key46316235-d24f-4f8e-a842-9ebc8e1656c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Free T4
Version Model NumberC76421
Catalog NumberC76421
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
GS115099590780982 [Primary]

FDA Product Code

CECRadioimmunoassay, Free Thyroxine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-20
Device Publish Date2024-03-12

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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