Duns Number:039981550
Device Description: HemaPRO Automated Hematology Stain Instrument. Intended to be used to automatically perfor HemaPRO Automated Hematology Stain Instrument. Intended to be used to automatically perform a hematology stain (Wright’s-Giemsa) sequence on a slide containing a biological specimen for in vitro diagnostic use.
Catalog Number
HP1
Brand Name
QuickSlide™
Version/Model Number
HP1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KPA
Product Code Name
Slide Stainer, Automated
Public Device Record Key
dac8537e-bd78-4fa2-bdbe-42ecf9c0f3ea
Public Version Date
September 02, 2022
Public Version Number
1
DI Record Publish Date
August 25, 2022
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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |