PreciControl Release Chagas 09367098190

GUDID 07613336183038

Trypanosoma cruzi total antibody IVD, control

Primary Device ID	07613336183038
NIH Device Record Key	7176f775-10d3-4276-ba09-bb7752e9bc8c
Commercial Distribution Status	In Commercial Distribution
Brand Name	PreciControl Release Chagas
Version Model Number	09367098190
Catalog Number	09367098190
Company DUNS	315028860
Company Name	Roche Diagnostics GmbH
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	false
Device Combination Product	false
Single Use	false
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	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	07613336183038 [Primary]

QHM	Serology tests used for infectious disease screening of blood and plasma donations

Steralize Prior To Use	false
Device Is Sterile	false