Duns Number:079686463
Device Description: Internal control used in real-time polymerase chain reaction (pcr) assays to detect system Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
Catalog Number
3804-21
Brand Name
MHV Control Primers 3
Version/Model Number
3804-21
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 02, 2021
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OLD
Product Code Name
Internal polymerase chain reaction control, not assay specific
Public Device Record Key
f38d437a-d25f-4bec-8bcc-41cb5017e84b
Public Version Date
March 03, 2021
Public Version Number
3
DI Record Publish Date
December 16, 2016
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 | 47 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |