MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) KR6215

GUDID B126KR62150

A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid peroxidase (TPO) receptor in human serum.

KRONUS, INC.

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay
Primary Device IDB126KR62150
NIH Device Record Key4885f0ea-4f6c-471c-b8b3-77110ddd0b2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
Version Model NumberKR6215
Catalog NumberKR6215
Company DUNS181070814
Company NameKRONUS, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB126KR62150 [Primary]

FDA Product Code

JZOSystem, Test, Thyroid Autoantibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-12-18

On-Brand Devices [MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)]

B126KR62150A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid p
B126KR62100A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid p

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