Alethia™ HSV 1&2 - The Alethia™ HSV 1&2 DNA amplification assay, - MERIDIAN BIOSCIENCE, INC.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

PGI

Product Code Name

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

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERIDIAN BIOSCIENCE, INC." Characteristics
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