TRU RSV - TRU RSV is a rapid, qualitative, lateral-flow - MERIDIAN BIOSCIENCE, INC.

Duns Number:092815364

Device Description: TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to be used by clinical laboratories to test specimens from symptomatic patients aged five years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture. The results of this test are used in combination with other clinical tests and the patients’ conditions to diagnose RSV-associated infections.

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More Product Details

Catalog Number

751330

Brand Name

TRU RSV

Version/Model Number

751330

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071101

Product Code Details

Product Code

GQG

Product Code Name

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

Device Record Status

Public Device Record Key

fa06a8be-f716-4805-b6bf-802631dc43a2

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERIDIAN BIOSCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 149
2 A medical device with a moderate to high risk that requires special controls. 46
3 A medical device with high risk that requires premarket approval 1