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

Devices Manufactured by Beckman Coulter, Inc.

• 15099590754488 - Access Total T4 II: 2025-09-29 The Access Total T4 II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of tota
• 15099590754495 - Access Total T4 II Calibrators: 2025-09-29 The Access Total T4 II Calibrators are intended to calibrate the Access Total T4 II assay for the quantitative determination of
• 15099590224301 - Access Vitamin B12: 2025-09-17 The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vita
• 15099590750312 - Cellmek: 2025-09-10 Cellmek SPS
• 15099590754013 - DxFLEX: 2025-09-10 DxFLEX Flow Cytometer
• 15099590701673 - Access Hybritech PSA: 2025-06-09 The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of to
• 15099590701680 - Access Hybritech free PSA: 2025-06-09 The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination
• 15099590763626 - Access Syphilis Reagent: 2025-05-15 The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibo