ImmunoStat G/C 30 Test Kit 750830

GUDID 00742860100017

SEKISUI DIAGNOSTICS, LLC

Multiple faecal parasite antigen IVD, kit, immunochromatographic test (ICT)

• Primary Device ID: 00742860100017
• NIH Device Record Key: b3821c0b-fab1-4f8d-afef-2a10588123f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoStat G/C 30 Test Kit
• Version Model Number: 750830
• Catalog Number: 750830
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00742860100017 [Primary]
GS1	10742860100014 [Unit of Use]

FDA Product Code

• MHI: GIARDIA SPP.

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: 2018-03-29
• Device Publish Date: 2017-01-10

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