OSOM RSV Test Home 1091

GUDID 10742860100663

OSOM RSV Test

SEKISUI DIAGNOSTICS, LLC

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Primary Device ID10742860100663
NIH Device Record Keycce24772-4a9e-493f-b42c-725e5c8f9d07
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSOM RSV Test Home
Version Model Number1091
Catalog Number1091
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100742860100666 [Primary]
GS110742860100663 [Unit of Use]

FDA Product Code

GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-27
Device Publish Date2025-05-19

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

10742860100663 - OSOM RSV Test Home2025-05-27OSOM RSV Test
10742860100663 - OSOM RSV Test Home2025-05-27 OSOM RSV Test
00628063401291 - Acetaminophen2023-05-16
00628063401307 - Acetaminophen Calibrator2023-05-16
00628063401314 - Alinity c Acetaminophen2023-05-16
00628063401321 - Alinity c Acetaminophen Calibrator2023-05-16
10742860100397 - OSOM ULTRA PLUS FLU A&B Test 2022-06-10
00628063401222 - DC-TROL LEVELS 1 & 22020-04-07
00628063400003 - Carbon Dioxide L3K2019-10-21

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