Access Total T4 II Calibrators C69048

GUDID 15099590754495

The Access Total T4 II Calibrators are intended to calibrate the Access Total T4 II assay for the quantitative determination of thyroxine levels in human serum and plasma using the automated Access Immunoassay Systems.

Beckman Coulter, Inc.

Thyroxine binding capacity IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590754495
NIH Device Record Key51e463a5-65f2-4a72-b168-16b77896218d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Total T4 II Calibrators
Version Model NumberC69048
Catalog NumberC69048
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
GS115099590754495 [Primary]

FDA Product Code

JISCalibrator, Primary

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.

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