FDA.reportPublic FDA data

Idylla™ Respiratory (IFV-RSV) Panel

Primary DI
15415219000635
Brand
Idylla™ Respiratory (IFV-RSV) Panel
Company
Biocartis NV
Model
1.0
Catalog number
A1030/6
Published
2018-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCCRespiratory Virus Panel Nucleic Acid Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163628000Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV2017-08-30OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15415219000635PrimaryGS10
05415219000638Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541521900063515415219000635
05415219000638054152190006385415219000638

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
400686169
Device count
6
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15415219001328Idylla CDx MSI Testv32025-11-01
05415219000119Idylla™ SystemIdylla™ InstrumentP00102017-08-21
05415219000126Idylla™ SystemIdylla™ ConsoleP10102017-08-21
15415219000758Idylla™ MSI Test22023-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2024-07-26
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOCC2024-05-03
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2023-05-09
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOCC2023-04-06
B540FAB1100CW0Accula Flu A / B TestMESA BIOTECH, INC.OCC2022-10-17
B540FAB1100CWC0Accula Flu A / B Control KitMESA BIOTECH, INC.OCC2022-10-17
10811877011221ID NOW Influenza A & B 2 Control Swab KitAlere Scarborough, Inc.OCC2022-08-05
20816101026962Simplexa™ Flu A/B & RSV Direct Gen IIDIASORIN MOLECULAR LLCOCC2020-08-29
B540D20010Accula Programming CassetteMESA BIOTECH, INC.OCC2020-06-08
B540D20000Accula Dock MESA BIOTECH, INC.OCC2020-04-13
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OCC2020-01-10
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOCC2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOCC2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOCC2019-12-05
B54010290Silaris RSV Control KitMESA BIOTECH, INC.OCC2019-07-29
B54010350Sialris Influenza A&B Supplemental PackMESA BIOTECH, INC.OCC2019-07-29
B54010400Silaris RSV Supplemental PackMESA BIOTECH, INC.OCC2019-07-29
04053228033905QIAstat-Dx® Respiratory PanelQIAGEN GmbHOCC2019-05-24
30014613336068SolanaDIAGNOSTIC HYBRIDS, INC.OCC2018-11-16
10811877010422ID NOW Influenza A & B 2Alere Scarborough, Inc.OCC2018-10-29
10811877010439ID NOW Influenza A & B Control Swab KitAlere Scarborough, Inc.OCC2018-10-29
10811877010521ID NOW RSVAlere Scarborough, Inc.OCC2018-10-29
10811877010538ID NOW RSV Control Swab KitAlere Scarborough, Inc.OCC2018-10-29
30014613336143SolanaDIAGNOSTIC HYBRIDS, INC.OCC2018-08-07
B54010240 Silaris Influenza A&B Control KitMESA BIOTECH, INC.OCC2018-03-15
B54010270Silaris Influenza A&B TestMESA BIOTECH, INC.OCC2018-03-15
B54010280SilarisTM Influenza A&B Starter PackMESA BIOTECH, INC.OCC2018-03-15
07332940000783Xpert FLU/RSV XCCEPHEIDOCC2018-01-29
07332940001070Xpert FluCEPHEIDOCC2018-01-29
07332940005177Xpert Flu+RSV XpressCEPHEIDOCC2018-01-29