FDA.reportPublic FDA data

Gram-Positive Blood Culture (BC-GP) Utility Tray

Primary DI
00857573006287
Brand
Gram-Positive Blood Culture (BC-GP) Utility Tray
Company
NANOSPHERE, INC.
Model
20-011-018
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
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN120014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN120014000VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)Nanosphere, Inc.2012-06-26PAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487101674PrimaryGS10
00857573006287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487101674008404871016748404871016740840487101674
00857573006287008575730062878575730062870857573006287

GMDN Terms#

Term, Definition table
TermDefinition
Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometryA 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 amplification/mass spectrometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature08 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-837-4436productsupport@nanosphere.us
+1(877)785-2323support@luminexcorp.com

Regulatory Flags#

DUNS number
164757242
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857573006027Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-0012016-09-23
00857573006348Hypercoagulation Panel (HC) Sample Buffer30-001-0012016-09-23
00857573006133Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge20-006-0202016-09-23
00857573006164Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge20-006-0242016-09-23
00857573006232Respiratory Virus Plus (RV+) Extraction Tray20-009-0202016-09-23
00857573006263Respiratory Pathogens Flex (RP Flex) Extraction Tray20-009-0242016-09-23
00857573006294Respiratory Virus Plus (RV+) Amplification Tray20-011-0202016-09-23
00857573006324Respiratory Pathogens Flex (RP Flex) Amplification Tray20-011-0242016-09-23
00857573006119Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge20-006-0182016-09-23
00857573006218Gram-Positive Blood Culture (BC-GP) Extraction Tray20-009-0182016-09-23
00857573006003 Verigene® Reader 10-0000-022016-09-23
00857573006010 Verigene® Processor SP 10-0000-072016-09-23
00857573006386 Verigene® Processor 10-0000-042016-09-23
00857573006393 Verigene® Reader (Refurbished)10-0000-02R2016-11-04
00857573006409 Verigene® Processor SP (Refurbished)10-0000-07R2016-11-04
00857573006041Enteric Pathogens (EP) Nucleic Acid Test Cartridge20-006-0232016-09-23
00857573006058Enteric Pathogens (EP) Extraction Tray20-009-0232016-09-23
00857573006065Enteric Pathogens (EP) Stool Sample Preparation Kit30-002-0232016-09-23
00857573006089Enteric Pathogens (EP) Amplification Tray20-011-0232016-09-23
00857573006140Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge20-006-0212016-09-23

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
00840487101575Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeLUMINEX CORPORATIONNQX2019-12-05
00840487101575Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeLUMINEX CORPORATIONPAM2019-12-05
00840487101629Gram-Positive Blood Culture (BC-GP) Extraction TrayLUMINEX CORPORATIONNQX2019-12-05
00840487101629Gram-Positive Blood Culture (BC-GP) Extraction TrayLUMINEX CORPORATIONPAM2019-12-05
00840487101674Gram-Positive Blood Culture (BC-GP) Utility TrayLUMINEX CORPORATIONNQX2019-12-05
00840487101674Gram-Positive Blood Culture (BC-GP) Utility TrayLUMINEX CORPORATIONPAM2019-12-05
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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
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