Access Thyroglobulin Sample Diluent 33866

GUDID 15099590225858

The Access Thyroglobulin Sample Diluent is intended for use with the Access Thyroglobulin Assay to dilute patient samples containing thyroglobulin (Tg

Beckman Coulter, Inc.

Thyroglobulin IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590225858
NIH Device Record Key8c8f23d7-01cd-4dcf-9103-aac2737b009b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Thyroglobulin Sample Diluent
Version Model Number33866
Catalog Number33866
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
GS115099590225858 [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

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