Access AMH B13127

GUDID 15099590669263

The Access AMH assay is paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels i

Beckman Coulter, Inc.

Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 15099590669263
• NIH Device Record Key: 0fe7738b-ebe4-4776-beb9-342567602a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access AMH
• Version Model Number: B13127
• Catalog Number: B13127
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	15099590669263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170524

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: 2018-04-16
• Device Publish Date: 2018-03-16

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