Duns Number:117458512
Device Description: The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitat The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection.
Catalog Number
RTK403ING
Brand Name
HSV 1&2 ELITe MGB Assay for CE-IVD
Version/Model Number
RTK403ING
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OOI
Product Code Name
Real Time Nucleic Acid Amplification System
Public Device Record Key
05c91df0-f11e-4dd6-bae7-d58f3f885b38
Public Version Date
October 15, 2020
Public Version Number
2
DI Record Publish Date
September 15, 2020
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 | 106 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |