FDA.reportPublic FDA data

MGB Alert Internal Control Set IC2-C -480 rxn QTY-25

Primary DI
03661540952296
Brand
MGB Alert Internal Control Set IC2-C -480 rxn QTY-25
Company
ELITECH GROUP INC.
Model
800432-25
Catalog number
800432-25
Device description
The MGB Alert Internal Control Set IC2-C consists of reagents intended for use as an un-assayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-C 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. QTY-25@480 reactions.
Published
2022-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
03661540952296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540952296036615409522963661540952296

GMDN Terms#

Term, Definition table
TermDefinition
Exogenous DNA internal control kit IVDA collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or to verify the absence of inhibiting substances in a clinical specimen.

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
079696864
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
03661540952371MGB Alert IC1 Internal Control Template (35uL volume)M8007352022-07-05
03661540952258MGB Alert Internal Control Set IC2-B, 480 rxn QTY-25800363-25800363-252022-04-04
03661540952265MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100800363-100800363-1002022-04-04
03661540952302 MGB Alert Internal Control Set IC2-C -480 rxn QTY-100800432-100800432-1002022-04-04
03661540952173MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 100800332-100800332-1002022-04-04
03661540952180MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-100800333-100800333-1002022-04-04
03661540952197MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-25 800350-25800350-252022-04-04
03661540952203MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-100800350-100800350-1002022-04-04
03661540952210MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-25800404-25800404-252022-04-04
03661540952227MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-100800404-100800404-1002022-04-04
03661540952272MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 25800332-25800332-252022-04-04
03661540952289MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-25800333-25800333-252022-04-04

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
03661540952418MGB Alert MS2 Internal Control DNA 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
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