Duns Number:312576506
Device Description: The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to h The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
Catalog Number
12008722
Brand Name
IH-Card ABO Neutral
Version/Model Number
12008722
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK210625
Product Code
KSZ
Product Code Name
System, Test, Automated Blood Grouping And Antibody
Public Device Record Key
cc66ca6a-b6c2-4fc1-9938-ca0481c62616
Public Version Date
March 17, 2022
Public Version Number
1
DI Record Publish Date
March 09, 2022
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 |