Duns Number:117458512
Device Description: The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MG The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Alert IC1 v3.0 Primers, and the MGB AlertIC1 DSQ Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acidextraction and amplification processes associated with real-time PCR assays.
Catalog Number
-
Brand Name
MGB Alert® Internal Control set IC1 DSQ
Version/Model Number
M800728
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
-
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
OLD
Product Code Name
Internal Polymerase Chain Reaction Control, Not Assay Specific
Public Device Record Key
b1460d3a-e405-4ade-937a-efa3782f5a05
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 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 | 106 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |