FDA.reportPublic FDA data

FilmArray® Pneumonia Panel (Pneumo)

Primary DI
00815381020185
Brand
FilmArray® Pneumonia Panel (Pneumo)
Company
BIOFIRE DIAGNOSTICS, LLC
Model
RFIT-ASY-0145
Device description
IVD reagent kit containing 6 tests
Published
2018-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QBHLower Respiratory Microbial Nucleic Acid Detection System
QDPRespiratory Panel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBHLower Respiratory Microbial Nucleic Acid Detection SystemMicrobiology2
QDPRespiratory PanelMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180966000
K212727000
K243222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180966000FilmArray Pneumonia PanelBiofire Diagnostics, LLC2018-11-09QDP
K212727000FilmArray Pneumonia PanelBiofire Diagnostics, LLC2021-09-22QDP
K243222000BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)Biofire Diagnostics, LLC (Biomerieux)2024-11-06QDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815381020185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815381020185008153810201858153810201850815381020185

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
079280262
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
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini4245372024-07-26
00815381020055BIOFIRE ® SPOTFIRE ® Control StationFAST-ASY-00012023-04-06
00815381020352BIOFIRE ® SPOTFIRE ® Control StationFAST-ASY-0001-W2023-04-06
00815381020369BIOFIRE ® SPOTFIRE ® ModuleFAST-ASY-00022023-04-06
00815381020376BIOFIRE ® SPOTFIRE ® ModuleFAST-ASY-0002-W2023-04-06
00815381029058FilmArray® 2.0 InstrumentFLM2-ASY-0001-W2021-06-21
00815381029072FilmArray® Torch System BaseHTFA-ASY-0001-W2021-06-21
00815381029089FilmArray® Torch ModuleHTFA-ASY-0003-W2021-06-21
00815381020017FilmArray® InstrumentFLM1-ASY-0001FLM1-ASY-00012016-09-23
00815381020024FilmArray® InstrumentFLM1-ASY-0001FLM1-ASY-0001R2016-09-23
00815381020031FilmArray® 2.0 InstrumentFLM2-ASY-0001FLM2-ASY-00012016-09-23
00815381020048FilmArray® 2.0 InstrumentFLM2-ASY-0001FLM2-ASY-0001R2016-09-23
00815381020253FilmArray® Torch System BaseHTFA-ASY-0104HTFA-ASY-01042016-08-01
00815381020260FilmArray® Torch System BaseHTFA-ASY-0104HTFA-ASY-0104R2016-09-23
00815381020277FilmArray® Torch ModuleHTFA-SUB-0103HTFA-SUB-01032016-08-10
00815381020284FilmArray® Torch ModuleHTFA-SUB-0103HTFA-SUB-0103R2016-09-23
00815381020208BioFire® Joint Infection (JI) PanelRFIT-ASY-01352025-02-18
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelRFIT-ASY-01482025-02-18
00815381020888BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid4248982025-02-18
00815381020963BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid4250892025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260364750058UnyveroCuretis GmbHQBH2020-01-15
00815381020178FilmArray® Pneumonia Panel (Pneumo)BIOFIRE DIAGNOSTICS, LLCQDP2018-12-12
00815381020178FilmArray® Pneumonia Panel (Pneumo)BIOFIRE DIAGNOSTICS, LLCQBH2018-12-12
04260364750003UnyveroCuretis GmbHQBH2018-05-28
04260364750010UnyveroCuretis GmbHQBH2018-05-28
04260364750027UnyveroCuretis GmbHQBH2018-05-28
04260364750034UnyveroCuretis GmbHQBH2018-05-28
04260364750041UnyveroCuretis GmbHQBH2018-05-28