FDA.reportPublic FDA data

TRU RSV

Primary DI
00840733101847
Brand
TRU RSV
Company
MERIDIAN BIOSCIENCE, INC.
Model
751330
Catalog number
751330
Device description
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.
Published
2020-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071101000TRU RSVMeridian Bioscience, Inc.2007-10-18GOG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101847008407331018478407331018470840733101847

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or 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. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-343-3858MBI-TechService@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950921308096CLUNGENEHangzhou Clongene Biotech Co., Ltd.GQG2026-04-11
00742860100666OSOM RSV Test HomeSEKISUI DIAGNOSTICS, LLCGQG2025-05-19
10742860100663OSOM RSV Test HomeSEKISUI DIAGNOSTICS, LLCGQG2025-05-19
20612479277278McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2025-05-14
40612479277289McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2025-05-14
00810160810377Red TunicaRodimedi & Associates, Inc.GQG2025-03-14
00810160810360Red TunicaRodimedi & Associates, Inc.GQG2025-03-14
00612479269880McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2024-09-09
00612479269897McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2024-09-09
00895160002854Nano-Check RSV TestNANO-DITECH CORPORATIONGQG2024-08-08
05032384502950IMAGEN Respiratory Syncytial Virus (RSV)OXOID LIMITEDGQG2024-06-19
10722066008031Rapid ResponseBTNX IncGQG2024-02-21
00722066008034Rapid ResponseBTNX IncGQG2024-02-21
08033891327668CHORUS RESPIRATORY SYNCYTIAL VIRUS IgGDIESSE DIAGNOSTICA SENESE SPAGQG2024-01-22
10694644700036Easy Lab Pro RSVAMERICAN BIO MEDICA CORPORATIONGQG2023-01-12
00840733101977FLU/RSV Positive ControlMERIDIAN BIOSCIENCE, INC.GQG2020-11-17
10811877010484BinaxNOW Nasopharyngeal Swab Accessory KitAlere Scarborough, Inc.GQG2020-09-16
10811877011160BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011177BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011184BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011191BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011207BinaxNOW RSV Control Swab KitAlere Scarborough, Inc.GQG2020-09-16
30014613201939QuickVueQUIDEL CORPORATIONGQG2018-11-10
30014613202226QuickVueQUIDEL CORPORATIONGQG2018-11-10
30014613202424SofiaQUIDEL CORPORATIONGQG2018-11-10
30014613202608SofiaQUIDEL CORPORATIONGQG2018-11-10
00382902560388BD Veritor™ System For Rapid Detection of RSV - CLIA waived kitBECTON, DICKINSON AND COMPANYGQG2018-05-25
00382902560425BD Veritor™ System For Rapid Detection of RSV - Laboratory kitBECTON, DICKINSON AND COMPANYGQG2018-05-25
10627966005183RAMP® RSV TEST KIT; 25 TESTSResponse Biomedical CorpGQG2017-08-31
10627966005206RAMP® RSV Control SwabsResponse Biomedical CorpGQG2017-08-31