Duns Number:312576506
Device Description: IH-Centrifuge L for centrifugation of IH-System gel cards and/or test tubes.
Catalog Number
-
Brand Name
IH-Centrifuge L
Version/Model Number
009301
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
-
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
BK170065
Product Code
PBC
Product Code Name
Manual Blood Grouping And Antibody Test Systems
Public Device Record Key
0d5234fc-998d-4258-ab22-72fed07a86b8
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
April 05, 2018
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 |