FDA.reportPublic FDA data

MGB Alert® Full Process Control FPC1

Primary DI
03661540953194
Brand
MGB Alert® Full Process Control FPC1
Company
Elitechgroup Mdx LLC
Model
M800842
Catalog number
M800842
Device description
Product Intended Use The MGB Alert® Full Process Control FPC1 is intended to be used as an exogenous polymerase chain reaction (PCR) internal control. The control can be used to detect systemic variations or failure of nucleic acid extraction, reverse transcription and DNA amplification processes associated with real-time PCR assays. This reagent is intended to be added to PCR samples prior or during the nucleic acid extraction step. Product description The MGB Alert Full Process Control FPC1 is a ready-to-use suspension (in 1X TE buffer) of purified, protein packaged fragment of MS2 RNA containing an artificial IC1 sequence. The product has been optimized for use in combination with the IC1 primers (REF: M400813, M400464) and IC1 probe (REF: M400812, M400655) to efficiently reverse transcribe, PCR amplify and detect the IC1 sequence.
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
03661540953194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540953194036615409531943661540953194

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-833-227-3400mdx@elitechgroup.com

Regulatory Flags#

DUNS number
117458512
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540952777MGB Alert® BKV ASR v3.0 Primer MixM8007322026-11-05
03661540953200MGB Alert® Full Process Control FPC2M800843M8008422026-11-05
03661540953330DSQ Alert® Borrelia Primer Mix ASRM800869M8008692026-11-05
03661540953347DSQ Alert® Borrelia Probe Mix ASRM800870M8008702026-11-05
03661540953217DSQ Alert Hepatitis E Primer Mix ASRM800854M8008542026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRM800855M8008552026-08-07
03661540952319MGB Alert® BKV ASR v3.0 Primer MixM8007322022-09-30
03661540953170DSQ Alert HT Adenovirus Primer Mix ASRM800860M8008602026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRM800861M8008612026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661540953200MGB Alert® Full Process Control FPC2Elitechgroup Mdx LLCOLD2026-11-05
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
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