INVADER

INVADER - INVADER MTHFR 677, 1680 TESTS

A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the genetic disorder methylenetetrahydrofolate reductase (MTHFR) deficiency, an inborn error of folate metabolism associated with mutation in the MTHFR gene, using a nucleic acid technique (NAT).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OMM

Device Name: Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

Device Class: 2

Physical State: genotyping test system

Definition: In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia.

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses DNA genotyping technology to determine patient genotype at the 5, 10-methylenetetrahydrofolate reductase gene locus.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: clinical samples (blood, saliva, buccal swab samples)

Regulation Number: 864.7280

Third Party Flag: Y

Medical Specialty: HE

Device Id: 15420045506718

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A