Duns Number:212623821
Device Description: Shigella Antisera Set 2 - A set containing 8 polyvalent and 11 monovalent antisera for ser Shigella Antisera Set 2 - A set containing 8 polyvalent and 11 monovalent antisera for serotyping Shigella, dysenteriae, Shigella flexneri, Shigella boydii and Shigella sonnei strains
Catalog Number
M10105
Brand Name
Shigella Antisera Set 2
Version/Model Number
M10105
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
-
Product Code
GNB
Product Code Name
Antisera, All Types, Shigella Spp.
Public Device Record Key
16e68aea-9f07-475c-a276-01e56de79c14
Public Version Date
September 17, 2018
Public Version Number
1
DI Record Publish Date
August 17, 2018
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |