Duns Number:195501127
Device Description: HemataChek is a three-level micro-hematocrit reference control for monitoring the accuracy HemataChek is a three-level micro-hematocrit reference control for monitoring the accuracy and presision of the HemataStat™Centrifuges and other methods used to measure whole blood spun hematacit values.
Catalog Number
300-101
Brand Name
HemataChek Normal Control
Version/Model Number
300-101
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
-
Product Code
GLK
Product Code Name
Control, Hematocrit
Public Device Record Key
fd68df0a-7556-4abe-925d-db1be6057f37
Public Version Date
April 18, 2018
Public Version Number
3
DI Record Publish Date
August 25, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |