IMMUNOCARD STAT C/G Control Set 750820

GUDID 00742860100000

SEKISUI DIAGNOSTICS, LLC

Multiple faecal parasite antigen IVD, control

• Primary Device ID: 00742860100000
• NIH Device Record Key: 865ebaa1-5c8d-4e76-bf67-5956e31c5e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMUNOCARD STAT C/G Control Set
• Version Model Number: 750820
• Catalog Number: 750820
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00742860100000 [Primary]

FDA Product Code

• JTR: KIT, QUALITY CONTROL FOR CULTURE MEDIA

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: 2016-09-16

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