Duns Number:084963177
Device Description: Microplate Washer
Catalog Number
-
Brand Name
405LSHTV-SI
Version/Model Number
405LSHTV-SI
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
JQW
Product Code Name
STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
Public Device Record Key
b39b74a8-2c0d-46ea-88a5-1e386acf70ff
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
June 01, 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 | 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 |