Duns Number:061446282
Device Description: This reagent is intended for the detection of the M antigen on red blood cells by tube tes This reagent is intended for the detection of the M antigen on red blood cells by tube test.
Catalog Number
0004802
Brand Name
Anti-M (Murine Monoclonal) Gamma-clone
Version/Model Number
0004802
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
-
Product Code
-
Product Code Name
-
Public Device Record Key
7a92f07e-374f-4e50-b9dd-f0aa0cfeceb3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 04, 2016
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |