Alethia™ Mycoplasma Direct External Control Kit 479890

GUDID 00840733102103

The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Alethia Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.

MERIDIAN BIOSCIENCE, INC.

Mycoplasma pneumoniae nucleic acid IVD, control

• Primary Device ID: 00840733102103
• NIH Device Record Key: a272f516-33a8-4771-a8b4-5ce36a8face2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alethia™ Mycoplasma Direct External Control Kit
• Version Model Number: 479890
• Catalog Number: 479890
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, INC.
• 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: 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

Customer Support Contacts

• Phone: 513-271-3700
• Email: info@meridianbioscience.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733102103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160829

FDA Product Code

• OZX: Mycoplasma Pneumoniae Dna Assay System

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: 2019-02-08
• Device Publish Date: 2019-01-08

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