Duns Number:561011079
Device Description: 32B Automated Viral RNA Isolation Kit is intended for isolation and purification of viral 32B Automated Viral RNA Isolation Kit is intended for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs and saliva ) by using automatic magnetic beads technology, The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained.
Catalog Number
3000000000147
Brand Name
32B Automated Viral RNA Isolation Kit
Version/Model Number
64 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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
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
147a87b1-5eea-4f70-b3e6-bde3e2d078cf
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 |