FDA.reportPublic FDA data

MGB Alert 2X PCR Master Mix 48 rxn

Primary DI
03661540951787
Brand
MGB Alert 2X PCR Master Mix 48 rxn
Company
Elitechgroup Mdx LLC
Model
M800331
Catalog number
M800331
Device description
The MGB Alert PCR Master Mix package includes ready to use 2x master mix containinga non-Taq thermostable enzyme lacking exonuclease activity and provided in antibodyinactivated form. An initial high-temperature incubation step denatures the antibodies toactivate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) anddUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mMMgCl2 are provided for additional flexibility in optimizing reaction conditions.
Published
2020-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540951787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540951787036615409517873661540951787

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid amplification mastermix kit IVDA collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls 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)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-453-2725MDx@elitechgroup.com

Regulatory Flags#

DUNS number
117458512
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540953149DSQ Alert® HT Pneumocystis jirovecii Primer Mix M800849M8008492026-05-12
03661540953156DSQ Alert® HT Pneumocystis jirovecii Probe MixM800850M8008502026-05-12
03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnM800845M8008452026-03-24
03661540953125DSQ Alert Measles Probe Mix ASR, 48 rxnM800846M8008462026-03-24
03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnM800847M8008472026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnM800848M8008482026-03-24
03661540952722DSQ Alert HHV7 Primer Mix ASRM800766M8007662025-10-14
03661540952739DSQ Alert HHV7 Probe Mix ASRM800767M8007672025-10-14
03661540950001MRSA/SA ELITe MGBM8003462016-10-13
03661540951411MGB Alert Internal Control Set IC2-480 rxn8003628003622020-09-15
03661540951862MGB Alert®Internal Control 1C Set, 480 rxn8003618003612020-09-15
03661540951336MGB Alert HHV-6 Primer Mix ASR - 480 rxn8003388003382020-09-14
03661540951770MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions8004348004342020-09-08
03661540952906MGB Alert® HDV Primer Mix ASRM800817M8008172025-10-15
03661540952913MGB Alert HDV Probe Mix ASRM800818M8008182025-10-15
03661540952517MGB Alert 2X ELITaq Master Mix, 48rxnM800809M8008092023-02-03
03661540952524MGB Alert ELITaq Master Mix, 480 rxnM800810M8008102023-02-03
03661540950278MGB Alert Platinum Master Mix-48 rxnM800599M8005992020-09-15
03661540951725MGB Alert 2X PCR Master Mix 480 rxnM800547M8005472020-09-15
03661540951756MGB Alert One-Step Reverse Transcriptase PCR Master Mix M800689M8006892020-09-15

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