Access Free T3 A13422

GUDID 15099590201661

The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590201661
NIH Device Record Keyb64fb8e4-a1c5-4737-95b2-d1432e18e0ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Free T3
Version Model NumberA13422
Catalog NumberA13422
Company DUNS008254708
Company NameBeckman Coulter, Inc.
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 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
GS115099590201661 [Primary]

FDA Product Code

CDPRadioimmunoassay, Total Triiodothyronine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-04
Device Publish Date2023-06-26

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