Elecsys AMH 08819378190

GUDID 07613336166291

Roche Diagnostics GmbH

Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336166291
• NIH Device Record Key: 2df1b906-f15a-49cb-b6fe-84b32b89b53b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys AMH
• Version Model Number: 08819378190
• Catalog Number: 08819378190
• 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	07613336166291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203757

FDA Product Code

• PQO: Anti-Müllerian hormone test system

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: 2022-07-28
• Device Publish Date: 2022-07-20

On-Brand Devices [Elecsys AMH]

• 07613336166291: 08819378190
• 07613336166284: 08819319160