Access Total T4 II C69047

GUDID 15099590754488

The Access Total T4 II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 is used, along with other laboratory tests, as an aid in the diagnosis and management of thyroid dysfunction.

Beckman Coulter, Inc.

Thyroxine binding capacity IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590754488
NIH Device Record Keya9533703-dba4-40de-9994-1e9c319d1290
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Total T4 II
Version Model NumberC69047
Catalog NumberC69047
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
GS115099590754488 [Primary]

FDA Product Code

KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-29
Device Publish Date2025-09-19

Devices Manufactured by Beckman Coulter, Inc.

15099590754488 - Access Total T4 II2025-09-29The Access Total T4 II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 is used, along with other laboratory tests, as an aid in the diagnosis and management of thyroid dysfunction.
15099590754488 - Access Total T4 II2025-09-29 The Access Total T4 II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of tota
15099590754495 - Access Total T4 II Calibrators2025-09-29 The Access Total T4 II Calibrators are intended to calibrate the Access Total T4 II assay for the quantitative determination of
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