FDA.reportPublic FDA data

MGB Alert IC1 Internal Control Template (35uL volume)

Primary DI
03661540952371
Brand
MGB Alert IC1 Internal Control Template (35uL volume)
Company
ELITECH GROUP INC.
Model
M800735
Device description
The MGB Alert Internal Control Set IC1 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 IC1 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.
Published
2022-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
03661540952371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540952371036615409523713661540952371

GMDN Terms#

Term, Definition table
TermDefinition
Exogenous DNA/RNA 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 ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Less or equal to -10C Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
425.482.5555mdx@elitechgroup.com

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
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
03661540952296 MGB Alert Internal Control Set IC2-C -480 rxn QTY-25800432-25800432-252022-04-04
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
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