Duns Number:312576506
Device Description: Fully automated system for immunohematology diagnostics
Catalog Number
001100
Brand Name
IH-1000
Version/Model Number
001100
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
BK140106,BK170019,BK200548
Product Code
KSZ
Product Code Name
System, Test, Automated Blood Grouping And Antibody
Public Device Record Key
940cd34d-9d97-4e3f-990b-ea34cbbc1d1a
Public Version Date
September 16, 2022
Public Version Number
8
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 |