Sperm Antibody ELISA

GUDID 05400569000841

Sperm Antibody ELISA

Diasource Immunoassays S.A. SA

Sperm antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 05400569000841
• NIH Device Record Key: 6a681fd9-17d1-4f0b-b6dc-7205d4cbdd78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sperm Antibody ELISA
• Version Model Number: KAPD1826
• Company DUNS: 458777323
• Company Name: Diasource Immunoassays S.A. SA
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05400569000841 [Primary]

FDA Product Code

• DFQ: SPERM, ANTIGEN, ANTISERUM, CONTROL

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: 2020-01-17
• Device Publish Date: 2020-01-09

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