CareSuperb COVID-19 Antigen Home Test

GUDID 00850010224435

Access Bio Inc.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00850010224435
• NIH Device Record Key: 7baddb5a-43ac-4f48-a813-5b71e6641fe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareSuperb COVID-19 Antigen Home Test
• Version Model Number: RCTM-00571
• Company DUNS: 116671434
• Company Name: Access Bio 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: 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	00850010224435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241915

FDA Product Code

• QYT: Over-The-Counter Covid-19 Antigen Test

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: 2026-01-13
• Device Publish Date: 2026-01-05

On-Brand Devices [CareSuperb COVID-19 Antigen Home Test]

• 00850010224435: RCTM-00571
• 00850010224305: RCTM-00271
• 00850010224275: RCTM-00171