FDA.reportPublic FDA data

Respiratory Pathogens Flex (RP Flex) Extraction Tray

Primary DI
00857573006263
Brand
Respiratory Pathogens Flex (RP Flex) Extraction Tray
Company
NANOSPHERE, INC.
Model
20-009-024
Device description
The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
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
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
OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
OZZBordetella Pertussis Dna Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
OZEInfluenza A And Influenza B Multiplex Nucleic Acid AssayMicrobiology2
OZZBordetella Pertussis Dna Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143653000Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc.2015-09-04OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487101667PrimaryGS10
00857573006263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487101667008404871016678404871016670840487101667
00857573006263008575730062638575730062630857573006263

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus 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 one or multiple viruses associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 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
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
00857573006287Gram-Positive Blood Culture (BC-GP) Utility Tray20-011-0182016-09-23
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

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Primary DI, Brand, Company table
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