Duns Number:844766394
Device Description: HSV Type 2 Specific IgG EIA Test Set
Catalog Number
12008531
Brand Name
Bio-Rad
Version/Model Number
12008531
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
K152353
Product Code
MYF
Product Code Name
Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2
Public Device Record Key
13c9e4f1-81a2-4185-a4ad-e22681195d63
Public Version Date
January 23, 2020
Public Version Number
2
DI Record Publish Date
May 28, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 98 |
3 | A medical device with high risk that requires premarket approval | 30 |