SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box

GUDID 00810172700000

WatMIND USA

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Primary Device ID00810172700000
NIH Device Record Key9619512b-17c0-4f8d-a2c8-22e5cb4ec6f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box
Version Model NumberSpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-T
Company DUNS117617770
Company NameWatMIND USA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810172700000 [Primary]

FDA Product Code

QYTOver-The-Counter Covid-19 Antigen Test

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-18
Device Publish Date2024-07-10

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

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