Premier HpSA Flex 619096

GUDID 00840733101472

The Premier HpSA Flex enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

MERIDIAN BIOSCIENCE, INC.

Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840733101472
• NIH Device Record Key: 7e4f9771-1ae2-43b9-8ce8-5bf4b15bb2a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier HpSA Flex
• Version Model Number: 619096
• Catalog Number: 619096
• 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: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com
• Phone: 513-271-3700
• Email: MBI-TechService@meridianbioscience.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733101472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230901

FDA Product Code

• LYR: Helicobacter Pylori

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: 2023-09-05
• Device Publish Date: 2023-08-28

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