AccessGUDID - DEVICE: Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge (00857573006027)

GUDID

Device Identifier (DI) Information

Brand Name: Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge
Version or Model: 20-006-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NANOSPHERE, INC.

Primary DI Number: 00857573006027
Issuing Agency: GS1
Commercial Distribution End Date: December 05, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 164757242 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55996	Multiple coagulation factor IVD, kit, clotting	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NPQ	Test, Factor V Leiden Mutations, Genomic Dna Pcr
OMM	Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
NPR	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070597	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f324433-2392-47dc-a0d2-b923649cd640
Public Version Date: December 06, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016