CareSuperb COVID-19/FluA&B Antigen Combo Home Test

GUDID 00850010224381

Access Bio Inc.

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00850010224381
• NIH Device Record Key: 7c0a3c3f-58a6-4792-9bda-0757dc18e316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareSuperb COVID-19/FluA&B Antigen Combo Home Test
• Version Model Number: RCUM-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	00850010224381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251604

FDA Product Code

• SCA: Multi-Analyte Respiratory Virus Antigen Detection 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: 2026-01-01
• Device Publish Date: 2025-12-24

Devices Manufactured by Access Bio Inc.

• 00850010224275 - CareSuperb COVID-19 Antigen Home Test: 2026-01-13
• 00850010224305 - CareSuperb COVID-19 Antigen Home Test: 2026-01-13
• 00850010224435 - CareSuperb COVID-19 Antigen Home Test: 2026-01-13
• 00850010224381 - CareSuperb COVID-19/FluA&B Antigen Combo Home Test: 2026-01-01
• 00850010224381 - CareSuperb COVID-19/FluA&B Antigen Combo Home Test: 2026-01-01