Elecsys Prolactin II 09755764190

GUDID 07613336218426

Roche Diagnostics GmbH

Prolactin IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336218426
• NIH Device Record Key: 9be1d513-b135-48f7-bad3-2c02bf7c02c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Prolactin II
• Version Model Number: 09755764190
• Catalog Number: 09755764190
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613336218426 [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: 2024-10-16
• Device Publish Date: 2024-10-08

On-Brand Devices [Elecsys Prolactin II]

• 04015630921546: 03203093190
• 07613336218426: 09755764190