CARTON-RDB1V10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)

GUDID 40810172700091

WatMIND USA

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Primary Device ID40810172700091
NIH Device Record Key388b7397-eee4-4048-88e5-0ce079d16e7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARTON-RDB1V10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)
Version Model NumberCARTON-RDB1V10-SAN-Speedy Swab Rapid COVID-19 & FL
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
GS140810172700091 [Primary]

FDA Product Code

QKPCoronavirus Antigen Detection Test System.

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-16
Device Publish Date2024-08-08

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

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