Elecsys HCG Test System 08890587190

GUDID 07613336169216

Roche Diagnostics GmbH

Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336169216
• NIH Device Record Key: 9aa8677e-e52f-44db-9d07-6d64f1533908
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys HCG Test System
• Version Model Number: 08890587190
• Catalog Number: 08890587190
• 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	07613336169216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203227

FDA Product Code

• DHA: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

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: 2021-10-04
• Device Publish Date: 2021-09-24

On-Brand Devices [Elecsys HCG Test System]

• 07613336169223: 08890595190
• 07613336169216: 08890587190