Duns Number:561011079
Device Description: The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads tech The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads technology for isolation and purification of Pathogen nucleic acid from biological specimens. The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques.
Catalog Number
3000000000359
Brand Name
ReadiMag Pathogen Nucleic Acid Isolation Kit
Version/Model Number
32 Tests
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
JJH
Product Code Name
Clinical Sample Concentrator
Public Device Record Key
197a12e3-a3f2-476c-9732-1be5f9fd610d
Public Version Date
August 01, 2022
Public Version Number
1
DI Record Publish Date
July 22, 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 | 14 |