Duns Number:988298840
Device Description: MicroTrak® HSV 1 /HSV 2 Direct Specimen - Collection Kit
Catalog Number
8H329UL
Brand Name
MicroTrak®
Version/Model Number
8H329UL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GQL
Product Code Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Public Device Record Key
1668852c-2028-4295-9f4e-5a7a21b90cef
Public Version Date
May 10, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
05391516746137
Quantity per Package
20
Contains DI Package
05391516748643
Package Discontinue Date
January 01, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |