Duns Number:328712260
Device Description: Pierceable Adhesive Seals for 96 Well Plates for automated sample preparation, Vitamin C Pierceable Adhesive Seals for 96 Well Plates for automated sample preparation, Vitamin C in plasma/serum
Catalog Number
65759
Brand Name
Accessorie
Version/Model Number
65759
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2022
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
JMA
Product Code Name
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Public Device Record Key
a8923d83-007d-4024-a765-c9e99a8896f6
Public Version Date
July 11, 2022
Public Version Number
2
DI Record Publish Date
August 27, 2020
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 | 455 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |