FDA.reportPublic FDA data

BioCode Respiratory Pathogen Panel

Primary DI
00851034007073
Brand
BioCode Respiratory Pathogen Panel
Company
APPLIED BIOCODE, INC.
Model
01
Catalog number
63-R0001
Device description
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
Published
2020-01-10
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
NSUInstrumentation For Clinical Multiplex Test Systems
OCCRespiratory Virus Panel Nucleic Acid Assay System
OEMHuman Metapneumovirus (Hmpv) Rna Assay System
OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay
OOUParainfluenza Multiplex Nucleic Acid Assay
OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay
OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
OZXMycoplasma Pneumoniae Dna Assay System
OZYChlamydophila Pneumoniae Dna Assay System
OZZBordetella Pertussis Dna Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2
OEMHuman Metapneumovirus (Hmpv) Rna Assay SystemMicrobiology2
OEPInfluenza A Virus Subtype Differentiation Nucleic Acid AssayMicrobiology2
OOUParainfluenza Multiplex Nucleic Acid AssayMicrobiology2
OTGNon-Sars Coronavirus Multiplex Nucleic Acid AssayMicrobiology2
OZEInfluenza A And Influenza B Multiplex Nucleic Acid AssayMicrobiology2
OZXMycoplasma Pneumoniae Dna Assay SystemMicrobiology2
OZYChlamydophila Pneumoniae Dna Assay SystemMicrobiology2
OZZBordetella Pertussis Dna Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192485000BioCode Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.2019-12-23OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851034007073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851034007073008510340070738510340070730851034007073

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory pathogen nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple different microorganisms typically associated with respiratory disease and/or one or multiple genes conferring antimicrobial resistance in microorganisms present in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8332462633atang@apbiocode.com

Regulatory Flags#

DUNS number
004580003
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851034007004BioCode MDx 3000141-A00512018-10-15
00851034007028BioCode MDx 3000 Optical Calibration and Verification Kit164-C00022019-07-30
00851034007011Gastrointestinal Pathogen Panel (GPP) Kit12018-10-15
00851034007035BioCode MDx 3000 Buffer A12019-07-30
00851034007042BioCode SA-PE Mix Pack12019-07-30
00851034007059BioCode 2500 Multiplex Detection System141-A00052018-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840487101438LIAISON PLEX Gastrointestinal Flex AssayLUMINEX CORPORATIONNSU2026-06-08
07613336206355cobas® 6800 systemRoche Molecular Systems, Inc.NSU2026-03-26
07613336206362cobas® 8800 systemRoche Molecular Systems, Inc.NSU2026-03-26
15420045517059Aptima®Hologic, Inc.NSU2024-12-19
15420045517080Aptima®Hologic, Inc.NSU2024-12-19
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCOZE2024-07-26
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2024-07-26
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZY2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZX2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZE2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOTG2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOCC2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOEM2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOOU2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCNSU2024-05-03
M70880113943T2Biothreat® Reagent TraysT2 BIOSYSTEMS, INC.NSU2023-11-07
M70885113963T2Biothreat® QCheck Positive Kit T2 BIOSYSTEMS, INC.NSU2023-11-07
M70885113983T2Biothreat® QCheck Negative KitT2 BIOSYSTEMS, INC.NSU2023-11-07
M70890114000T2Biothreat® Cartridge KitT2 BIOSYSTEMS, INC.NSU2023-11-07
15420045511880Aptima®Hologic, Inc.NSU2023-10-26
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOTG2023-05-09
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2023-05-09
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOZE2023-05-09
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOTG2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZE2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZZ2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOOU2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOEM2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZX2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZY2023-04-06