Elecsys Total PSA CalSet II 04485220160

GUDID 04015630920754

Total prostate specific antigen (tPSA) IVD, calibrator

Primary Device ID	04015630920754
NIH Device Record Key	8126a47b-f5c0-4a99-893a-d3cf8d8f0c50
Commercial Distribution Discontinuation	2019-01-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Elecsys Total PSA CalSet II
Version Model Number	04485220160
Catalog Number	04485220160
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	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	true
OTC Over-The-Counter	false

Storage Environment Temperature

Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	04015630920754 [Primary]

MTF	TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER

Steralize Prior To Use	false
Device Is Sterile	false