FDA.reportPublic FDA data

Gram-Negative Blood Culture (BC-GN) Utility Tray

Primary DI
00840487101698
Brand
Gram-Negative Blood Culture (BC-GN) Utility Tray
Company
LUMINEX CORPORATION
Model
20-011-021
Catalog number
20-011-021
Device description
The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
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
PENGram-Negative bacteria and associated resistance markers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PENGram-Negative Bacteria And Associated Resistance MarkersMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132843000VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)Nanosphere, Inc.2014-01-08PEN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857573006300PreviousGS10
00840487101698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857573006300008575730063008575730063000857573006300
00840487101698008404871016988404871016980840487101698

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 Temperature0-20 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
00840487101841LIAISON PLEX Gram-Negative Blood Culture AssayLUMINEX CORPORATIONPEN2025-06-11
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPEN2025-02-18
00815381020338BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPEN2020-07-02
00840487101599Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test CartridgeLUMINEX CORPORATIONPEN2019-12-05
00840487101643Gram-Negative Blood Culture (BC-GN) Extraction TrayLUMINEX CORPORATIONPEN2019-12-05
00857167005283ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005290ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005306ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005313ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005320ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005337ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
B769ICCAAQA00000iC-GN AssayICUBATE, INCPEN2019-07-15
00862011000321Accelerate Pheno™ SystemACCELERATE DIAGNOSTICS, INC.PEN2017-03-20
00857573006140Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test CartridgeNANOSPHERE, INC.PEN2016-09-23
00857573006249Gram-Negative Blood Culture (BC-GN) Extraction TrayNANOSPHERE, INC.PEN2016-09-23
00857573006300Gram-Negative Blood Culture (BC-GN) Utility TrayNANOSPHERE, INC.PEN2016-09-23
00815381020086FilmArray® BCID PanelBIOFIRE DIAGNOSTICS, LLCPEN2016-09-23
00815381020093FilmArray® BCID PanelBIOFIRE DIAGNOSTICS, LLCPEN2016-09-23