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

GUDID 50810172700081

WatMIND USA

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

• Primary Device ID: 50810172700081
• NIH Device Record Key: 9131db58-1719-4943-868b-cf37f71f3d33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speedy Swab Rapid COVID-19 & FLU A&B Self-Test
• Version Model Number: CARTON-2V300-Speedy Swab Rapid COVID-19 & FLU A+B
• 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	50810172700081 [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: 2024-09-09
• Device Publish Date: 2024-08-30

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

• 50810172700098: CARTON-1V500-Speedy Swab Rapid COVID-19 & FLU A+B
• 50810172700081: CARTON-2V300-Speedy Swab Rapid COVID-19 & FLU A+B