Elecsys Prolactin II 03203093190

GUDID 04015630921546

Prolactin IVD, kit, chemiluminescent immunoassay

Primary Device ID	04015630921546
NIH Device Record Key	437cc4d3-e959-4e3d-b67a-df688362cd1a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Elecsys Prolactin II
Version Model Number	03203093190
Catalog Number	03203093190
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	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	04015630921546 [Primary]

CFT	RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Steralize Prior To Use	false
Device Is Sterile	false