MHV Control Primers 1 3802

GUDID 00840487101155

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.

LUMINEX CORPORATION

Endogenous RNA internal control reagent IVD
Primary Device ID00840487101155
NIH Device Record Key0b13c393-ff6a-400c-bd20-d7ef58b106c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMHV Control Primers 1
Version Model Number3802
Catalog Number3802
Company DUNS079686463
Company NameLUMINEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)327-3290
Emailsupport@luminexcorp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840487101155 [Primary]

FDA Product Code

OLDInternal polymerase chain reaction control, not assay specific

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-16

On-Brand Devices [MHV Control Primers 1]

00840487101162Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var
00840487101155Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.