Access Thyroglobulin 33860

GUDID 15099590227173

The Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in

Beckman Coulter, Inc.

Thyroglobulin IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590227173
NIH Device Record Key583c29e2-9e7d-440e-ae68-3852d2391825
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Thyroglobulin
Version Model Number33860
Catalog Number33860
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
GS115099590227173 [Primary]

FDA Product Code

MSWSystem,Test,Thyroglobulin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-04-09
Device Publish Date2016-09-09

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.