DEVICE: MGB Alert 2X PCR Master Mix 48 rxn (03661540951787)
Device Identifier (DI) Information
MGB Alert 2X PCR Master Mix 48 rxn
M800331
In Commercial Distribution
M800331
Elitechgroup Mdx LLC
M800331
In Commercial Distribution
M800331
Elitechgroup Mdx LLC
The MGB Alert PCR Master Mix package includes ready to use 2x master mix containing
a non-Taq thermostable enzyme lacking exonuclease activity and provided in antibody
inactivated form. An initial high-temperature incubation step denatures the antibodies to
activate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) and
dUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mM
MgCl2 are provided for additional flexibility in optimizing reaction conditions.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60091 | Nucleic acid amplification mastermix kit IVD |
A collection of reagents and other associated materials [enzymes, buffers, nucleotides, magnesium chloride (MgCl2)], intended to be used in combination with sequence-specific primers, probes and/or controls (not included) to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] in a clinical specimen, using a nucleic acid amplification technique [e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PPM | General Purpose Reagent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than -10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c6f6f544-75fc-48ab-af1e-727e6183aa7c
April 18, 2025
3
September 15, 2020
April 18, 2025
3
September 15, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-453-2725
MDx@elitechgroup.com
MDx@elitechgroup.com