Duns Number:092815364
Device Description: The Alethia™ HSV 1&2 DNA amplification assay, performed on the Alethia™ Instrument, is a q The Alethia™ HSV 1&2 DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Alethia™ HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from Alethia™ HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.
Catalog Number
480650
Brand Name
Alethia™ HSV 1&2
Version/Model Number
480650
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151046
Product Code
PGI
Product Code Name
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Public Device Record Key
f0049e4c-9066-49cc-bfac-ec8824adaed9
Public Version Date
February 11, 2019
Public Version Number
1
DI Record Publish Date
January 09, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 149 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |
3 | A medical device with high risk that requires premarket approval | 1 |