Elecsys FSH 11775863122

GUDID 04015630909223

Roche Diagnostics GmbH

Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630909223
• NIH Device Record Key: a9c0bc5d-705c-45b2-945b-c5b6dc537fdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys FSH
• Version Model Number: 11775863122
• Catalog Number: 11775863122
• 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	04015630909223 [Primary]

FDA Product Code

• CGJ: RADIOIMMUNOASSAY, FOLLICLE-STIMULATING 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: 2020-03-23
• Device Publish Date: 2020-03-13

On-Brand Devices [Elecsys FSH]

• 04015630909223: 11775863122
• 07613336170380: 08932387190
• 07613336170373: 08932352190
• 07613336217801: 09745840190