Duns Number:061446282
Device Description: This reagent is used in slide, tube, microplate and automated tests, for the detection of This reagent is used in slide, tube, microplate and automated tests, for the detection of the A antigen of the ABO blood group system. The package configuration for this product code is one (1) vial of reagent.
Catalog Number
0006401
Brand Name
Anti-A (Murine Monoclonal) Series 1
Version/Model Number
0006401
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
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
173ea9ea-76a4-4947-a654-7f32d98a2f99
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2014
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 |