MGB Alert Internal Control Set IC2-8 48 rxn M800600

GUDID 03661540950322

The MGB Alert Internal Control Set IC2-8 consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-8 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.

ELITECH GROUP INC.

Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA internal control kit IVD Exogenous DNA/RNA internal control kit IVD Exogenous DNA/RNA internal control kit IVD Exogenous DNA/RNA internal control kit IVD Exogenous DNA/RNA internal control kit IVD Exogenous DNA/RNA internal control kit IVD Exogenous DNA/RNA internal control kit IVD Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit Exogenous DNA/RNA internal control IVD, kit
Primary Device ID03661540950322
NIH Device Record Key19e61903-f0f3-4a51-9619-d80376c9291d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGB Alert Internal Control Set IC2-8 48 rxn
Version Model NumberM800600
Catalog NumberM800600
Company DUNS079696864
Company NameELITECH GROUP INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com
Phone800-453-2725
EmailMDx@elitechgroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540950322 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-23
Device Publish Date2020-09-15

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03661540952210 - MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-252022-04-12 MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed
03661540952227 - MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-1002022-04-12 MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed
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