SpermMar Test IgG - single kit

GUDID 54119670000362

SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies. The SpermMar Test IgG is a diagnostic kit for detecting anti

Fertipro NV

Sperm antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 54119670000362
• 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
• Phone: +3250791805
• Email: info@fertipro.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	54119670000362 [Primary]

FDA Product Code

• KTO: Reagent, Immunoassay, Igg

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: 2018-09-24
• 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