Elecsys sFlT-1 09015353160

GUDID 07613336230671

Roche Diagnostics GmbH

Placental growth factor (PLGF) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336230671
• NIH Device Record Key: 961e1f1b-2d24-4d53-9bdd-432a5cc8f2aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys sFlT-1
• Version Model Number: 09015353160
• Catalog Number: 09015353160
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	07613336230671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241453

FDA Product Code

• QWH: Prognostic test for development or progression of preeclampsia

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: 2025-04-15
• Device Publish Date: 2025-04-07

On-Brand Devices [Elecsys sFlT-1]

• 07613336230671: 09015353160
• 07613336172094: 09015388190