MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) KR6210

GUDID B126KR62100

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay

Primary Device ID	B126KR62100
NIH Device Record Key	71d34974-dcff-4f3d-924c-b78713becb54
Commercial Distribution Status	In Commercial Distribution
Brand Name	MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
Version Model Number	KR6210
Catalog Number	KR6210
Company DUNS	181070814
Company Name	KRONUS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B126KR62100 [Primary]

JZO	System, Test, Thyroid Autoantibody

Steralize Prior To Use	false
Device Is Sterile	false

B126KR62150	A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid p
B126KR62100	A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid p