MedMira Rapid H. Pylori Antibody Test

GUDID 00628451188278

The MedMira Rapid H. Pylori Antibody Test is a rapid flow through test developed and manufactured by MedMira Laboratories Inc.

MedMira Laboratories Inc

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 00628451188278
• NIH Device Record Key: 4a3c692c-c0d1-401b-8115-7899ede9c437
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedMira Rapid H. Pylori Antibody Test
• Version Model Number: 815311003820
• Company DUNS: 243757049
• Company Name: MedMira Laboratories 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 902-450-1588
• Email: support@medmira.com
• Phone: 902-450-1588
• Email: support@medmira.com
• Phone: 902-450-1588
• Email: support@medmira.com
• Phone: 902-450-1588
• Email: support@medmira.com
• Phone: 902-450-1588
• Email: support@medmira.com
• Phone: 902-450-1588
• Email: support@medmira.com
• Phone: 902-450-1588
• Email: support@medmira.com
• Phone: 902-450-1588
• Email: support@medmira.com
• Phone: 902-450-1588
• Email: support@medmira.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628451188278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002023

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: 2024-07-17
• Device Publish Date: 2024-07-09

Devices Manufactured by MedMira Laboratories Inc

• 00628451188278 - MedMira Rapid H. Pylori Antibody Test: 2024-07-17The MedMira Rapid H. Pylori Antibody Test is a rapid flow through test developed and manufactured by MedMira Laboratories Inc.
• 00628451188278 - MedMira Rapid H. Pylori Antibody Test: 2024-07-17 The MedMira Rapid H. Pylori Antibody Test is a rapid flow through test developed and manufactured by MedMira Laboratories Inc.
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