Duns Number:212623821
Device Description: M10113 - Shigella boydii Polyvalent Typing Antiserum - POLY C1 Types 8, 9, 10, 11 - 2ml
Catalog Number
M10113
Brand Name
Mast Assure
Version/Model Number
M10113
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
15233bbd-f305-44a6-a6cf-2916d972f80a
Public Version Date
November 12, 2018
Public Version Number
1
DI Record Publish Date
October 10, 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 |