Duns Number:312576506
Device Description: Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing for use wi Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing for use with the IH-System
Catalog Number
-
Brand Name
IH-Basic QC
Version/Model Number
814171100
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
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
BK170075
Product Code
KSF
Product Code Name
Kit, Quality Control For Blood Banking Reagents
Public Device Record Key
dd94a958-19a9-4633-8616-d77502fbd2f7
Public Version Date
March 14, 2022
Public Version Number
4
DI Record Publish Date
February 28, 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 |