Duns Number:412925992
Device Description: HemoTrol® Duo is an assayed quality control material for professional use to verify the pe HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.
Catalog Number
AN01624A02
Brand Name
HemoTrol Duo
Version/Model Number
Normal
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
K192842,K192842
Product Code
GGM
Product Code Name
Control, Hemoglobin
Public Device Record Key
b3f7b57a-8c45-4df0-957b-60ec6c92b732
Public Version Date
December 30, 2019
Public Version Number
1
DI Record Publish Date
December 20, 2019
Package DI Number
08718734961246
Quantity per Package
2
Contains DI Package
08718734961215
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |