Duns Number:117458512
Device Description: The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an unassay The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1 can be used to detect systemicvariation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is notintended to monitor other real-time PCR processes.
Catalog Number
800427-am
Brand Name
MGB Alert Internal Control Set IC1, 09N39-001
Version/Model Number
800427-am
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
-
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
d2e2c676-a14c-4d37-a191-7bd7dc501a46
Public Version Date
August 30, 2022
Public Version Number
4
DI Record Publish Date
September 15, 2020
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 | 106 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |