Access Thyroglobulin Calibrators 33865

GUDID 15099590227166

The Access Thyroglobulin Calibrators are intended to calibrate the Access Thyroglobulin assay for the quantitative determination of thyroglobulin leve

Beckman Coulter, Inc.

Thyroglobulin IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590227166
NIH Device Record Key50b81c3e-f9ea-4bd0-94a0-1eb97f4804b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Thyroglobulin Calibrators
Version Model Number33865
Catalog Number33865
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
GS115099590227166 [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

Devices Manufactured by Beckman Coulter, Inc.

15099590209636 - DxH2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and
15099590762889 - Stem-Kit Reagents2024-11-04 Stem-Kit Reagents
15099590762896 - StemTrol Control Cells2024-11-04 StemTrol Control Cells
15099590732103 - DxI 9000 Access Immunoassay Analyzer2024-10-28 The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or quali
15099590575243 - Access hLH2024-05-01 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing
15099590760823 - Access NT-proBNP2024-04-29 The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-term
15099590760830 - ACCESS NT-proBNP CALIBRATORS2024-04-29 The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-te
15099590772840 - Access Ferritin2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti

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