MGB Alert® Internal Control set IC1 DSQ

GUDID 03661540952364

The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Alert IC1 v3.0 Primers, and the MGB Alert IC1 DSQ Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real-time PCR assays.

Elitechgroup Mdx LLC

Nucleic acid amplification primer IVD
Primary Device ID03661540952364
NIH Device Record Keyb1460d3a-e405-4ade-937a-efa3782f5a05
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGB Alert® Internal Control set IC1 DSQ
Version Model NumberM800728
Company DUNS117458512
Company NameElitechgroup Mdx LLC
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540952364 [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 Date2022-10-10
Device Publish Date2022-09-30

On-Brand Devices [MGB Alert® Internal Control set IC1 DSQ]

03661540952364The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Aler
03661540952333The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Aler

Trademark Results [MGB Alert]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MGB ALERT
MGB ALERT
78702861 3184945 Live/Registered
ELITECHGROUP B.V.
2005-08-29

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