FDA.reportPublic FDA data

Hypercoagulation Panel (HC) Sample Buffer

Primary DI
00857573006348
Brand
Hypercoagulation Panel (HC) Sample Buffer
Company
NANOSPHERE, INC.
Model
30-001-001
Device description
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
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
NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr
NPRTest, Factor Ii G20210a Mutations, Genomic Dna Pcr
OMMTest 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPQTest, Factor V Leiden Mutations, Genomic Dna PcrHematology2
NPRTest, Factor Ii G20210a Mutations, Genomic Dna PcrHematology2
OMMTest 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna PcrHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070597000VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TESTNanosphere, Inc.2007-10-11NSU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487101728PrimaryGS10
00857573006348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487101728008404871017288404871017280840487101728
00857573006348008575730063488575730063480857573006348

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen, using a clotting method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332940009519GeneXpert® CEPHEIDNPR2025-11-21
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX CORPORATIONNPQ2019-12-05
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOMM2019-12-05
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX CORPORATIONNPR2019-12-05
00840487101728Hypercoagulation Panel (HC) Sample BufferLUMINEX CORPORATIONNPR2019-12-05
00840487101728Hypercoagulation Panel (HC) Sample BufferLUMINEX CORPORATIONNPQ2019-12-05
00840487101728Hypercoagulation Panel (HC) Sample BufferLUMINEX CORPORATIONOMM2019-12-05
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00857573006027Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeNANOSPHERE, INC.OMM2016-09-23
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