Duns Number:695801965
Device Description: The RADI 192 Tissue DNA/RNA Extraction kit is a reagent intended to extract nucleic acids The RADI 192 Tissue DNA/RNA Extraction kit is a reagent intended to extract nucleic acids from fresh or frozen tissues and cultured cells. Automated nucleic acid extraction can be performed by using RADI 192 Extractor only. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS.The kit is intended to be used by a laboratory professional.
Catalog Number
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Brand Name
RADI 192 Tissue DNA/RNA Extraction Kit
Version/Model Number
OP004
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)
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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)
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FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
7edfc171-99b6-4382-9bdf-8e6ddf703c4f
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
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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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |