Hypercoagulation Panel (HC) Sample Buffer - The Verigene® Hypercoagulation Panel Nucleic - NANOSPHERE, INC.

Duns Number:164757242

Device Description: The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic 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.

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More Product Details

Catalog Number

-

Brand Name

Hypercoagulation Panel (HC) Sample Buffer

Version/Model Number

30-001-001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 05, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070597

Product Code Details

Product Code

NPQ

Product Code Name

Test, Factor V Leiden Mutations, Genomic Dna Pcr

Device Record Status

Public Device Record Key

04d11c06-af0c-4051-beed-3c60f37678e7

Public Version Date

December 06, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NANOSPHERE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 27