Dna Specimen Collection, Saliva

Device Code: 651

Product Code(s): OYJ

Definition: A Collection Device Intended For Use In The Non-invasive Collection Of Saliva Samples For Clinical Dna Testing.

Device Classification Information

Device Type ID651
Device NameDna Specimen Collection, Saliva
Physical StateSpecimen Collection Device
Technical MethodCollects DNA In Saliva And Stabilizes It For Transport Or Storage
Target AreaClinical Samples (saliva)
Regulation DescriptionBlood Specimen Collection Device.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.1675 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOYJ
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID651
DeviceDna Specimen Collection, Saliva
Product CodeOYJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionBlood Specimen Collection Device.
CFR Regulation Number862.1675 [🔎]
Premarket Reviews
ManufacturerDecision
DNA GENOTEK INC
 
SUBSTANTIALLY EQUIVALENT
1
DNA GENOTEK, INC.
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 19:38:07

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