INVADER - INVADER MTHFR 677, 144 TESTS
Device Description
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).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 15420045506671
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
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