Access hLH 33510

GUDID 15099590575243

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter, Inc.

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• Primary Device ID: 15099590575243
• NIH Device Record Key: 821a2b0f-cec6-44c4-b251-6c2a01d900cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access hLH
• Version Model Number: 33510
• Catalog Number: 33510
• 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	15099590575243 [Primary]

FDA Product Code

• CEP: Radioimmunoassay, Luteinizing Hormone

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: 2024-05-01
• Device Publish Date: 2024-04-23

On-Brand Devices [Access hLH]

• 15099590232276: The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitati
• 15099590575243: The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitati