Areta Strep A Swab Test Strip (25 tests kit)

GUDID 10850253007731

25 tests kit; Strep A Swab Test Strip

EASY HEALTHCARE CORPORATION

Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10850253007731
• NIH Device Record Key: ffd773fd-0d3e-4078-9956-d9c8b539d48a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Areta Strep A Swab Test Strip (25 tests kit)
• Version Model Number: ARST-100
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 25
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850253007734 [Primary]
GS1	10850253007731 [Package]; Contains: 00850253007734; Package: [20 Units]; In Commercial Distribution
GS1	30850253007735 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133343

FDA Product Code

• GTY: Antigens, All Groups, Streptococcus Spp.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Areta Strep A Swab Test Strip (25 tests kit)]

• 10850253007748: 25 tests kit; Strep A Swab Test Strip ( Individually wrapped)
• 10850253007731: 25 tests kit; Strep A Swab Test Strip