Elecsys LH 09755721190

GUDID 07613336218402

Roche Diagnostics GmbH

Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336218402
• NIH Device Record Key: d3ae25f3-906d-4991-8dd3-0eccc23a6540
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys LH
• Version Model Number: 09755721190
• Catalog Number: 09755721190
• 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	07613336218402 [Primary]

FDA Product Code

• CEP: RADIOIMMUNOASSAY, LUTEINIZING HORMONE

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: 2026-02-27
• Device Publish Date: 2026-02-19

On-Brand Devices [Elecsys LH]

• 04015630907410: 11732234122
• 07613336218402: 09755721190