Access Inhibin A A36097

GUDID 15099590203047

The Access Inhibin A assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of dimeric inhibin A in human s

Beckman Coulter, Inc.

Inhibin A IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 15099590203047
• NIH Device Record Key: 1cccfff7-bb27-40ed-a864-32cbb80bd9a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Inhibin A
• Version Model Number: A36097
• Catalog Number: A36097
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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	15099590203047 [Primary]

FDA Product Code

• NDR: Enzyme Immunoassay, Inhibin-A

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-09
• Device Publish Date: 2016-09-09

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