SpermMar Test IgG - single kit

GUDID 05411967000036

SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies. The SpermMar Test IgG is a diagnostic kit for detecting antisperm antibodies of the IgG class in human semen or serum. The direct SpermMar Test IgG can be performed on untreated human semen provided it contains motile spermatozoa, the indirect SpermMar Test IgG can be used on serum. 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: 05411967000036
• NIH Device Record Key: 40b31b05-ad95-47b9-9a08-6a1a0cc71c8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpermMar Test IgG - single kit
• Version Model Number: SPMG_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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05411967000036 [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 IgG - single kit]

• 54119670000362: SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies. The SpermMar
• 05411967000036: SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies. The SpermMar
• 05411967002559: SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies and consists of
• 05411967002542: SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies and consists of