Duns Number:084963177
Device Description: User-Fillable Reagent Bottle 25mL Capacity (Link)
Catalog Number
-
Brand Name
User-Fillable Reagent Bottle 25mL Capacity (Link)
Version/Model Number
SK202
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
74057676-950d-41db-8caf-18b4b6799432
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
September 17, 2020
Package DI Number
05700571112489
Quantity per Package
25
Contains DI Package
05700571104866
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 | 1076 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| 3 | A medical device with high risk that requires premarket approval | 8 |