FDA.reportPublic FDA data

INTROL CF Panel I Control

Primary DI
00852720008008
Brand
INTROL CF Panel I Control
Company
Mmqci
Model
v.02
Catalog number
G106ac-1
Device description
This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Published
2019-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZBQuality Control Material, Genetics, Dna

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZBQuality Control Material, Genetics, DnaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083171000INTROL CF PANEL I CONTROL, MODEL: G106Maine Molecular Quality Controls, Inc.2008-12-16NZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852720008008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852720008008008527200080088527200080080852720008008

GMDN Terms#

Term, Definition table
TermDefinition
Cystic fibrosis IVD, controlA material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Opened material returned to the refrigerator (2° – 8°C) shortly after use is stable for thirty (30) days from the date of opening.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
207-885-1072info@mmqci.com

Regulatory Flags#

DUNS number
172874245
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00852720008275FilmArray GI Control Panel M238v.00M2382025-12-04
00852720008336Birlinn BCR-ABL1 p210 IS Panel C230v.00C2302025-06-20
00852720008367Birlinn BCR-ABL1 p210 IS Control Panel C240v.00C2402025-06-20
00852720008145SPOTFIRE RSP Pos & Neg Controlsv.00M4252025-06-18
00852720008442Xpert BCR-ABL IS p210 Panel C206v.00C2062025-06-18
00852720008091SPOTFIRE RSP Positive Controlv.00M426382023-09-15
00852720008107SPOTFIRE RSP Negative Controlv.00M427382023-09-15
00852720008114BioFire RP2.1/RP2.1plus Control Panel M441v.00M4412021-09-16
00852720008046FilmArray RP EZ Control Panel M265v.00M2652020-01-22
00852720008039FilmArray RP2/RP2plus Control Panelv.00M3152019-12-31
00852720008183Xpert BCR-ABL IS p210 Linearity Panel C207v.00C2072023-09-15
00852720008121BioFire JI Control Panel M420v.00M4202022-11-14
00852720008077FilmArray BCID2 Control Panel M416v.00M4162021-02-18
00852720008053FilmArray Warrior Control Panel M290v.00M2902020-11-24
00852720008022FilmArray Pneumonia/Pneumoniaplus Controlv.00M3402019-06-17
00852720008084Xpert BCR-ABL 0%ISv.00C13112-52020-01-27
00852720008015INTROL CF Panel I Controlv.02G106ac2019-12-24
00852720008060Xpert BCR-ABL IS Panel C130v.00C1302019-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260712780034SensID Idylla™ MSI FFPE Reference Set SensID GmbHNZB2023-06-12
04260712780041SensID Idylla™ MSI FFPE Reference SetSensID GmbHNZB2023-06-12
04260712780065Idylla™ MSI FFPE Reference Set SensID GmbHNZB2023-06-12
04260712780003Idylla™ MSI FFPE Reference SetSensID GmbHNZB2022-10-26
00852720008015INTROL CF Panel I ControlMmqciNZB2019-12-24
08426950453086HemosIL FII & FV DNA ControlINSTRUMENTATION LABORATORY COMPANYNZB2016-09-23