Kidney KFRE Algorithm 09891986001

GUDID 07613336223321

Clinical management support software IVD

Primary Device ID	07613336223321
NIH Device Record Key	df8b31a1-b0db-49ca-94f7-1b99916b8692
Commercial Distribution Status	In Commercial Distribution
Brand Name	Kidney KFRE Algorithm
Version Model Number	09891986001
Catalog Number	09891986001
Company DUNS	315028860
Company Name	Roche Diagnostics GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	false
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
GS1	07613336223321 [Primary]

JQP	Calculator/data processing module, for clinical use

Steralize Prior To Use	false
Device Is Sterile	false