Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Device Code: 3563

Product Code(s): PGI

Definition: For The Qualitative Detection And Differentiation Of VZV, HSV1, HSV2- DNA In Cutaneous And Mucocutaneous Lesion Samples From Symptomatic Patients. The Assay Is Not Intended For Use With Cerebral Spinal Fluid.

Device Classification Information

Device Type ID3563
Device NameHerpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Physical StateReagent Assay Kit And Instrument
Technical MethodPolymerase Chain Reaction
Target AreaNot Applicable. In Vitro Diagnostic Device
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3309 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePGI
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3563
DeviceHerpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Product CodePGI
FDA Device ClassificationClass 2 Medical Device
CFR Regulation Number866.3309 [🔎]
Premarket Reviews
ManufacturerDecision
DIAGNOSTIC HYBRIDS, INC.
 
GRANTED
1
DIASORIN MOLECULAR LLC
 
SUBSTANTIALLY EQUIVALENT
1
ELITECHGROUP
 
SUBSTANTIALLY EQUIVALENT
1
LUMINEX CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
MERIDIAN BIOSCIENCE, INC.
 
SUBSTANTIALLY EQUIVALENT
1
MERIDIAN CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
1
QUIDEL CORP.
 
SUBSTANTIALLY EQUIVALENT
1
QUIDEL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 20:32:26

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