Duns Number:061446282
Device Description: This reagent is used in slide, tube and microplate tests, for the detection of the A and B This reagent is used in slide, tube and microplate tests, for the detection of the A and B antigens of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent.
Catalog Number
0414210
Brand Name
Anti-A,B (Murine Monoclonal) Gamma-clone Series 2
Version/Model Number
0414210
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
b36bd291-bf9b-471f-90d1-6ef45ee69f9d
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 |