Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge

GUDID 00857573006027

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.

NANOSPHERE, INC.

Multiple coagulation factor IVD, kit, clotting

• Primary Device ID: 00857573006027
• NIH Device Record Key: 9f324433-2392-47dc-a0d2-b923649cd640
• Commercial Distribution Discontinuation: 2019-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge
• Version Model Number: 20-006-001
• Company DUNS: 164757242
• Company Name: NANOSPHERE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487101513 [Primary]
GS1	00857573006027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070597

FDA Product Code

• NPQ: Test, Factor V Leiden Mutations, Genomic Dna Pcr
• OMM: Test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-06
• Device Publish Date: 2016-09-23

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