Duns Number:312576506
Device Description: A combination centrifuge and reader for IH gel cards
Catalog Number
001200
Brand Name
IH-Reader 24
Version/Model Number
001200
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
-
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
BK180225
Product Code
KSZ
Product Code Name
System, Test, Automated Blood Grouping And Antibody
Public Device Record Key
ee088105-c1c3-42bf-9711-eae0b8953375
Public Version Date
March 14, 2022
Public Version Number
3
DI Record Publish Date
January 10, 2019
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 |