Access Thyroglobulin Antibody II A32898

GUDID 15099590202910

The Access Thyroglobulin Antibody II (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyro

Beckman Coulter, Inc.

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA) Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID15099590202910
NIH Device Record Key6801e002-c737-4113-b882-db509f735d03
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Thyroglobulin Antibody II
Version Model NumberA32898
Catalog NumberA32898
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
GS115099590202910 [Primary]

FDA Product Code

JNLImmunochemical, Thyroglobulin Autoantibody

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 Antibody II]

15099590202910The Access Thyroglobulin Antibody II (TgAb) assay is a paramagnetic particle, chemiluminescent i
15099590763527The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoas

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