Access Thyroglobulin C71762

GUDID 15099590754501

Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.

Beckman Coulter, Inc.

Thyroglobulin IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590754501
NIH Device Record Key4edfaf4c-52bd-4df9-8ac4-b82177b5b027
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Thyroglobulin
Version Model NumberC71762
Catalog NumberC71762
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
GS115099590754501 [Primary]

FDA Product Code

MSWSystem,Test,Thyroglobulin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-11
Device Publish Date2023-12-01

On-Brand Devices [Access Thyroglobulin]

15099590227173The Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the
15099590754501Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quan

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.