No image

OSOM RSV Test

OSOM RSV TestOld UDI Package Number 50742860100661

Details

Device typeRespiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from respiratory syncytial virus (RSV) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

FDA categoryAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Device ID00742860100666

Catalog number1091

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

No contact is listed for this device.

Related products

Product	Model	Company	Device type
CVS HealthWoonsocket Prescription Center, IncorporatedMultiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing	641986	Woonsocket Prescription Center, Incorporated	Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing	20002608	Alere Scarborough, Inc.	Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
McKessonMckesson Medical-Surgical Inc.Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing	GCCOV-502a-MB	Mckesson Medical-Surgical Inc.	Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
iHealthiHealth Labs Inc.Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing	ICF-3000	iHealth Labs Inc.	Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing