Alethia™ Mycoplasma Direct 480250

GUDID 00840733102189

The Alethia Mycoplasma Direct DNA amplification assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The Alethia Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the Alethia Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the Alethia Mycoplasma Direct DNA Amplification Assay may be necessary.

MERIDIAN BIOSCIENCE, INC.

Mycoplasma pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00840733102189
• NIH Device Record Key: 20099556-e714-4378-a540-5c98587474db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alethia™ Mycoplasma Direct
• Version Model Number: 480250
• Catalog Number: 480250
• 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 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733102189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160829

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification 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

Devices Manufactured by MERIDIAN BIOSCIENCE, INC.

• 00840733103025 - Para-Pak Modified (Cu) PVA: 2023-10-25 Para-Pak based systems provide standardized procedures for the routine collection, transportation, preservation, and examination
• 00840733101472 - Premier HpSA Flex: 2023-09-05 The Premier HpSA Flex enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori ant
• 00840733101410 - Meridian Viral Transport: 2023-08-15 Meridian Viral Transport is a system which contains all materials necessary to collect and transport clinical specimens for vira
• 00840733103308 - Curian Shiga Toxin: 2023-06-05 The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simulta
• 00840733102387 - Curian Campy: 2023-03-31 Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campyloba
• 00840733103285 - Revogene Check: 2022-07-05 The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm th
• 00840733102844 - Para-Pak SAF: 2022-04-01 The Para-Pak SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool speci
• 00840733101434 - BreathTek UBT for H. pylori: 2022-02-21 The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated wi