AccessGUDID - DEVICE: MHV RNA Amplification Control (00840487101131)

GUDID

Device Identifier (DI) Information

Brand Name: MHV RNA Amplification Control
Version or Model: 3695
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3695
Company Name: LUMINEX CORPORATION

Primary DI Number: 00840487101131
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 079686463 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62401	Endogenous RNA internal control reagent IVD	A substance or reactant intended to be used as an endogenous component in a molecular assay to verify the extraction and/or amplification process applied to target ribonucleic acid (RNA), and/or verify the absence of inhibiting substances, in a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OLD	Internal polymerase chain reaction control, not assay specific

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -30 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54fccad8-4fbb-4056-92c2-99825d3bb81c
Public Version Date: March 03, 2021
Public Version Number: 3
DI Record Publish Date: December 16, 2016