Elecsys Prolactin II 03203093190

GUDID 04015630921546

Roche Diagnostics GmbH

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630921546 [Primary]

FDA Product Code

• CFT: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-22
• Device Publish Date: 2020-05-14

On-Brand Devices [Elecsys Prolactin II]

• 04015630921546: 03203093190
• 07613336218426: 09755764190