FSH CalSet II 09557440190

GUDID 07613336203590

Roche Diagnostics GmbH

Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator Follicle stimulating hormone (FSH) IVD, calibrator

• Primary Device ID: 07613336203590
• NIH Device Record Key: fede122f-b9dc-4857-be27-ff8485384842
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FSH CalSet II
• Version Model Number: 09557440190
• Catalog Number: 09557440190
• 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	07613336203590 [Primary]

FDA Product Code

• JIT: Calibrator, secondary

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: 2023-09-26
• Device Publish Date: 2023-09-18

On-Brand Devices [FSH CalSet II]

• 07613336170397: 08932417190
• 07613336203590: 09557440190