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Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge

Primary DI
00840487101575
Brand
Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge
Company
LUMINEX CORPORATION
Model
20-006-018
Catalog number
20-006-018
Device description
The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).
Published
2019-12-05
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
NQXSYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
PAMGram-positive bacteria and their resistance markers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenMicrobiology2
PAMGram-Positive Bacteria And Their Resistance MarkersMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857573006119PreviousGS10
00840487101575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857573006119008575730061198575730061190857573006119
00840487101575008404871015758404871015750840487101575

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type bloodstream 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 acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)785-2323support@luminexcorp.com

Regulatory Flags#

DUNS number
080778937
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-00120-006-0012019-12-05
00840487101728Hypercoagulation Panel (HC) Sample Buffer30-001-00130-001-0012019-12-05
00840487101858LIAISON PLEX Gram-Positive Blood Culture Assay20-005-30520-005-3052025-07-11
00840487101865LIAISON PLEX Yeast Blood Culture Assay Kit20-005-30620-005-3062024-10-22
00840487101940LIAISON PLEX® Respiratory Flex Assay Kit20-005-32220-005-3222024-06-20
00840487101841LIAISON PLEX Gram-Negative Blood Culture Assay20-005-30320-005-3032025-06-11
00840487100127MHV Control Primers 5380638062016-12-16
00840487100233MultiCode® Chlamydophila pneumoniae Primers392539252016-12-16
00840487100240MultiCode® Legionella pneumophila Primers392639262016-12-16
00840487100257MultiCode® Mycoplasma pneumoniae Primers392739272016-12-16
00840487101049MHV DNA Sample Processing Control370037002016-12-16
00840487101056MHV DNA Sample Processing Control3700-023700-022016-12-16
00840487101063MHV DNA Sample Processing Control3700-213700-212016-12-16
00840487101070MHV DNA Sample Processing Control3700-223700-222016-12-16
00840487101087MHV DNA Sample Processing Control371037102016-12-16
00840487101100MHV DNA Amplification Control369436942016-12-16
00840487101155MHV Control Primers 1380238022016-12-16
00840487101179MHV Control Primers 2380338032016-12-16
00840487101186MHV Control Primers 23803-213803-212016-12-16
00840487101193MHV Control Primers 3380438042016-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONPAM2025-07-11
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPAM2025-02-18
00815381020338BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPAM2020-07-02
00840487101629Gram-Positive Blood Culture (BC-GP) Extraction TrayLUMINEX CORPORATIONPAM2019-12-05
00840487101629Gram-Positive Blood Culture (BC-GP) Extraction TrayLUMINEX CORPORATIONNQX2019-12-05
00840487101674Gram-Positive Blood Culture (BC-GP) Utility TrayLUMINEX CORPORATIONNQX2019-12-05
00840487101674Gram-Positive Blood Culture (BC-GP) Utility TrayLUMINEX CORPORATIONPAM2019-12-05
00840487101445ARIES® MRSA AssayLUMINEX CORPORATIONNQX2019-10-08
00857167005283ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005290ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005306ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005313ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005320ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005337ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
B769ICCAAJA00000iC-GPC AssayICUBATE, INCPAM2019-07-10
07332940000141Xpert MRSA/SA Blood CultureCEPHEIDNQX2018-01-29
07332940000158Xpert SA Nasal CompleteCEPHEIDNQX2018-01-29
07332940000165Xpert SA Nasal CompleteCEPHEIDNQX2018-01-29
07332940000189Xpert MRSA/SA SSTICEPHEIDNQX2018-01-29
07332940000196Xpert MRSACEPHEIDNQX2018-01-29
07332940001711Xpert MRSA NxGCEPHEIDNQX2018-01-29
07332940001728Xpert MRSA NxGCEPHEIDNQX2018-01-29
07332940002442Xpert MRSACEPHEIDNQX2018-01-29
00382904434199BD MAX™ StaphSRBECTON, DICKINSON AND COMPANYNQX2017-04-12
00382904434618BD MAX™ MRSA XTBECTON, DICKINSON AND COMPANYNQX2017-04-12
03661540950001MRSA/SA ELITe MGBElitechgroup Mdx LLCNQX2016-10-13
B178GBSIDR100Staph ID/R Blood Culture PanelGREAT BASIN SCIENTIFIC, INC.PAM2016-09-23
00857573006119Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeNANOSPHERE, INC.NQX2016-09-23
00857573006119Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeNANOSPHERE, INC.PAM2016-09-23
00857573006218Gram-Positive Blood Culture (BC-GP) Extraction TrayNANOSPHERE, INC.NQX2016-09-23