Duns Number:540156544
Device Description: 1296-026 DELFIA Platewash is a washer designed for automatic washing of microtitration str 1296-026 DELFIA Platewash is a washer designed for automatic washing of microtitration strips or plates. It is self-contained, having built-in pumps for vacuum and dispensing and supplied with all the bottles and tubing needed for operation. For use with DELFIA analytes, ready-made programs are accessible.
Catalog Number
1296-026
Brand Name
DELFIA Platewash
Version/Model Number
1296-026
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
LXG
Product Code Name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Public Device Record Key
af13a737-4f10-4636-a0d0-ad3cfd92905a
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 04, 2021
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 |