QwikID IG06020C03

GUDID 00816576027439

QwikID H. pylori Rapid Antigen Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. 20 cassettes, ID 00816576027439;20 Sample preparation tubes, ID 00816576028030 and 1 Positive control reagent, ID 00816576028047

HARDY DIAGNOSTICS

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 00816576027439
• NIH Device Record Key: 2a1c3df1-8c7e-484a-869d-e3ef43653047
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QwikID
• Version Model Number: IG06020C03
• Catalog Number: IG06020C03
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 20
• 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

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
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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	00816576027439 [Unit of Use]
GS1	00816576028481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183573

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: 2025-07-01
• Device Publish Date: 2025-06-23

Devices Manufactured by HARDY DIAGNOSTICS

• 00816576027439 - QwikID: 2025-07-01QwikID H. pylori Rapid Antigen Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. 20 cassettes, ID 00816576027439;20 Sample preparation tubes, ID 00816576028030 and 1 Positive control reagent, ID 00816576028047
• 00816576027439 - QwikID: 2025-07-01 QwikID H. pylori Rapid Antigen Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antig
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• 00819398027779 - N/A: 2025-03-18 Anaerobe Nitrate Reagent B, Cleve's Acid for nitrate reduction test, formulated especially for anaerobic bacteria Hardy Diagnost
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• 00816576026951 - N/A: 2024-07-16 G Vag Starch Agar, 15x100mm Monoplate. For the selective isolation and differentiation of Gardnerella vaginalis from other micro
• 00816576026586 - N/A: 2024-04-05 Hektoen Enteric (HE) Agar / SS Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Hektoen Enteric (HE) Agar is a selective an
• 00816576026876 - N/A: 2024-03-18 C. auris Enrichment Broth, Fill 2mL (Sabouraud Salt Dulcitol Broth with Chloramphenicol & Gentamicin) For the selective enrichme