Duns Number:227530649
Device Description: This product is intended for in vitro diagnostic use in the quality control of multiple ha This product is intended for in vitro diagnostic use in the quality control of multiple haematology parameters
Catalog Number
HM5162
Brand Name
HAEM CNTL - LEVEL 1, 2, 3
Version/Model Number
HM5162
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K913879
Product Code
JPK
Product Code Name
Mixture, Hematology Quality Control
Public Device Record Key
c20a35d5-cf06-4aa7-b92b-aab034afac84
Public Version Date
September 05, 2022
Public Version Number
3
DI Record Publish Date
September 26, 2016
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |