Duns Number:276816717
Device Description: Specific tips for eMAG system which is intended for the automated isolation (purification Specific tips for eMAG system which is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens. For in vitro diagnostic use
Catalog Number
-
Brand Name
EMAG® TIPS 1000µL
Version/Model Number
EMAG® TIPS 1000µL
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
Yes
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
JJH
Product Code Name
CLINICAL SAMPLE CONCENTRATOR
Public Device Record Key
61a96dfc-6e43-4eef-ae14-8b454a28d760
Public Version Date
September 26, 2022
Public Version Number
3
DI Record Publish Date
May 20, 2020
Package DI Number
03573026489434
Quantity per Package
10
Contains DI Package
03573026615253
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |