Duns Number:312576506
Device Description: Blood Grouping Reagent; Gel card for use with IH-system; Optional add on to standard ABO t Blood Grouping Reagent; Gel card for use with IH-system; Optional add on to standard ABO typing cards; 48 cards of 6 microtubes
Catalog Number
813141100
Brand Name
IH-Card Group A,B
Version/Model Number
813141100
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
bf0c7eac-85b1-4ece-8e0c-44f27926bf4f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 20, 2017
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| U | Unclassified | 21 |