Duns Number:561011079
Device Description: The 96B Automated Viral RNA Isolation Kit is a system that uses automatic magnetic beads t The 96B Automated Viral RNA Isolation Kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or saliva). 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
3000000000145
Brand Name
96B Automated Viral RNA Isolation Kit
Version/Model Number
96 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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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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
677c1307-51bc-40ae-8835-8f478a022704
Public Version Date
May 16, 2022
Public Version Number
1
DI Record Publish Date
May 06, 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 |