Simplexa™ C.difficile Sample Prep Kit

GUDID 20816101025613

DIASORIN MOLECULAR LLC

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 20816101025613
• NIH Device Record Key: 420b0fa1-21d7-4d11-acc3-cafae10481a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplexa™ C.difficile Sample Prep Kit
• Version Model Number: MOL5290
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• Device Count: 1
• 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: 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

Customer Support Contacts

• Phone: (800) 838-4548
• Email: technicalinfo.molecular@diasor
• Phone: (800) 838-4548
• Email: technicalinfo.molecular@diasor

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101025613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163085

FDA Product Code

• OZN: C.Difficile Toxin Gene Amplification Assay

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-16

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