MHV Control Primers 3 - Internal control used in real-time polymerase - LUMINEX CORPORATION

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.

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More Product Details

Catalog Number

3804

Brand Name

MHV Control Primers 3

Version/Model Number

3804

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

0507407e-3c6a-4cce-aafd-456e318c9283

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUMINEX CORPORATION" Characteristics
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