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MGB Alert MS2 Internal Control DNA Template (250uL volume)

Primary DI
03661540952418
Brand
MGB Alert MS2 Internal Control DNA Template (250uL volume)
Company
Elitechgroup Mdx LLC
Model
M800739
Device description
The MGB Alert Internal Control MS2 DNA Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Published
2022-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OLDInternal Polymerase Chain Reaction Control, Not Assay Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLDInternal Polymerase Chain Reaction Control, Not Assay SpecificClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540952418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540952418036615409524183661540952418

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid amplification primer IVDA defined piece of single-stranded nucleic acid intended to be used to initiate the amplification of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)]. It is typically used to detect and/or identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion).

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
03661540953170DSQ Alert HT Adenovirus Primer Mix ASRM800860M8008602026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRM800861M8008612026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRM800854M8008542026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRM800855M8008552026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRM800867M8008672026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRM800868M8008682026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661540952760DSQ Alert® Internal Control set IC1 Elitechgroup Mdx LLCOLD2024-10-24
03661540952791DSQ Alert Internal Control set IC1 Elitechgroup Mdx LLCOLD2024-07-29
03661540952098DSQ Alert™ MS2-ICB-1 Internal Control SetElitechgroup Mdx LLCOLD2023-09-21
03661540951992MGB Alert MS2 RNA Internal Control in TE-Yeast RNAElitechgroup Mdx LLCOLD2023-03-06
03661540952555DSQ Alert Internal Control Set IC2Elitechgroup Mdx LLCOLD2022-12-12
03661540952333MGB Alert® Internal Control set IC1 DSQElitechgroup Mdx LLCOLD2022-09-30
03661540952364MGB Alert® Internal Control set IC1 DSQElitechgroup Mdx LLCOLD2022-09-30
03661540952388MGB Alert IC1 Internal Control Template Elitechgroup Mdx LLCOLD2022-08-30
03661540952395MGB Alert IC2 Internal Control Template Elitechgroup Mdx LLCOLD2022-08-30
03661540952401MGB Alert IC2 Internal Control Template (250uL volume)Elitechgroup Mdx LLCOLD2022-08-30
03661540952425MGB Alert MS2 Internal Control RNA Template (480uL volume)Elitechgroup Mdx LLCOLD2022-08-30
03661540952371MGB Alert IC1 Internal Control Template (35uL volume)ELITECH GROUP INC.OLD2022-07-05
03661540952258MGB Alert Internal Control Set IC2-B, 480 rxn QTY-25ELITECH GROUP INC.OLD2022-04-04
03661540952265MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100ELITECH GROUP INC.OLD2022-04-04
03661540952296 MGB Alert Internal Control Set IC2-C -480 rxn QTY-25ELITECH GROUP INC.OLD2022-04-04
03661540952302 MGB Alert Internal Control Set IC2-C -480 rxn QTY-100ELITECH GROUP INC.OLD2022-04-04
03661540950032MGB Alert Internal Control Set IC2-BH 48 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540950124MGB Alert Internal Control Set IC2-B, 09N38-001Elitechgroup Mdx LLCOLD2020-09-15
03661540950155MGB Alert Internal Control Set IC1, 09N39-001Elitechgroup Mdx LLCOLD2020-09-15
03661540950186MGB Alert Internal Control Set IC1-A, 09N40-001Elitechgroup Mdx LLCOLD2020-09-15
03661540950247MGB Alert Internal Control Set IC2-TElitechgroup Mdx LLCOLD2020-09-15
03661540950254MGB Alert Internal Control Set IC2-T, 09N42-001Elitechgroup Mdx LLCOLD2020-09-15
03661540950322MGB Alert Internal Control Set IC2-8 48 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951237MGB Alert Internal Control Set IC1-L 48 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951404MGB Alert Internal Control Set IC1 -480rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951411MGB Alert Internal Control Set IC2-480 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951428MGB Alert Internal Control Set IC2-B, 480 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951435MGB Alert Internal Control Set MS2-M 48 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951442MGB Alert Internal Control Set MS2-EElitechgroup Mdx LLCOLD2020-09-15
03661540951589MGB Alert Internal Control Set IC1 -48rxnElitechgroup Mdx LLCOLD2020-09-15