Duns Number:540156544
Device Description: For staining hemoglobin.
Catalog Number
FR-9367
Brand Name
RESOLVE Systems JB-2 Staining System
Version/Model Number
FR-9367
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
K050709
Product Code
GKA
Product Code Name
Abnormal Hemoglobin Quantitation
Public Device Record Key
070868df-591b-4ca5-960f-1974b774b7d9
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
February 02, 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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| 3 | A medical device with high risk that requires premarket approval | 2 |