Speedy Swab Rapid COVID-19 & FLU A+B Self-Test

GUDID 60810172700071

WatMIND USA

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

• Primary Device ID: 60810172700071
• NIH Device Record Key: 5fac3da8-6539-4f3a-b08d-807e1928df00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speedy Swab Rapid COVID-19 & FLU A+B Self-Test
• Version Model Number: CARTON-RDB-4V-4VUS4C30-BIO
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	60810172700071 [Primary]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

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: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [Speedy Swab Rapid COVID-19 & FLU A+B Self-Test ]

• 60810172700071: CARTON-RDB-4V-4VUS4C30-BIO
• 50810172700074: CARTON-RDB-4V-4VUS4C30-SAN