ACCESS PROLACTIN 33530

GUDID 15099590575229

The Access Prolactin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prolactin (PRL) levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

Beckman Coulter, Inc.

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• Primary Device ID: 15099590575229
• NIH Device Record Key: d511233a-4103-4172-ada7-07507e12b86c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCESS PROLACTIN
• Version Model Number: 33530
• Catalog Number: 33530
• 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	15099590575229 [Primary]

FDA Product Code

• CFT: Radioimmunoassay, Prolactin (Lactogen)

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: 2021-09-13
• Device Publish Date: 2021-09-03

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