Duns Number:540156544
Device Description: Wallac 1296-071 DBS Puncher is a microprocessor controlled automatic puncher for DELFIA® t Wallac 1296-071 DBS Puncher is a microprocessor controlled automatic puncher for DELFIA® tests performed on filter paper in microplate format. It punches out a disk from a bloodspot on filter paper; this disk then falls into a microtitration well. Punch disk size depends on the punch head installed. Up to 99 disks can be punched into the same well. When the selected number of disks has been punched for a well, the plate is moved to the next position so that the next disk(s) can be punched out. Up to two plates can be loaded to DBS puncher. A microtitration 96-well format plate and Corning Costar deep well tray can be loaded at the same time. Plates consisting of twelve eight-well strips are also supported.
Catalog Number
1296-071
Brand Name
Wallac DBS Puncher
Version/Model Number
1296-071
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
-
Product Code
LXG
Product Code Name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Public Device Record Key
fa4dfb4f-1da6-4e6c-8f59-7fd9ee785933
Public Version Date
May 08, 2019
Public Version Number
1
DI Record Publish Date
April 30, 2019
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 |