RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)

GUDID 20810172700080

WatMIND USA

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 20810172700080
• NIH Device Record Key: de6c1232-cfcf-481d-bd13-fe993689ff79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)
• Version Model Number: RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self
• Company DUNS: 117617770
• Company Name: WatMIND USA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	20810172700080 [Primary]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-16
• Device Publish Date: 2024-08-08

Devices Manufactured by WatMIND USA

• 50810172700081 - Speedy Swab Rapid COVID-19 & FLU A&B Self-Test: 2024-09-09
• 50810172700098 - Speedy Swab Rapid COVID-19 & FLU A&B Self-Test: 2024-09-09
• 00810172700079 - Speedy Swab Rapid COVID-19 & FLU A+B (4 Tests/Box): 2024-08-16
• 00810172700086 - Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box): 2024-08-16
• 00810172700093 - Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box): 2024-08-16
• 10810172700083 - RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box): 2024-08-16
• 10810172700090 - RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box): 2024-08-16
• 20810172700080 - RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box): 2024-08-16
• 20810172700080 - RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box): 2024-08-16