MGB Alert Internal Control Set IC1-A, 09N40-001 - The MGB Alert Internal Control Set IC1-A consists - Elitechgroup Mdx LLC

Duns Number:117458512

Device Description: The MGB Alert Internal Control Set IC1-A consists of reagents intended for use as an unass The MGB Alert Internal Control Set IC1-A 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-A can be used to detectsystemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set isnot intended to monitor other real-time PCR processes.

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More Product Details

Catalog Number

800495-am

Brand Name

MGB Alert Internal Control Set IC1-A, 09N40-001

Version/Model Number

800495-am

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

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 Details

Product Code

OLD

Product Code Name

Internal Polymerase Chain Reaction Control, Not Assay Specific

Device Record Status

Public Device Record Key

48cd7b2e-eba5-4c1c-8a8e-9b3cc1c01ab2

Public Version Date

August 30, 2022

Public Version Number

4

DI Record Publish Date

September 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELITECHGROUP MDX LLC" Characteristics
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