SpermMar Test IgA - single kit

GUDID 05411967002566

SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class. The Spermar Test IgA is a diagnostic kit for detecting antisperm antibodies of the IgA class in human semen. The presence of antisperm antibodies can interfere with sperm function and zona binding and the acrosome reaction. More information can be found at the FertiPro website: www.fertipro.com

Fertipro NV

Sperm antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 05411967002566
• NIH Device Record Key: 1a3ed3cf-04e2-4658-8b50-fc92a554b8a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpermMar Test IgA - single kit
• Version Model Number: SPMA_S
• Company DUNS: 373904101
• Company Name: Fertipro NV
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3250791805
• Email: info@fertipro.com

Device Dimensions

• Total Volume: 0.7 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05411967000029 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	05411967002566 [Primary]

FDA Product Code

• KTO: Reagent, Immunoassay, Igg

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-08-22

On-Brand Devices [SpermMar Test IgA - single kit]

• 54119670000294: SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class
• 05411967002566: SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class