MAINE MOLECULAR QUALITY CONTROLS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005959679	3005959679	MAINE MOLECULAR QUALITY CONTROLS, INC.	1	N	2026-01-01	23 Mill Brook Rd Saco ME US 04072

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
77633	1072309529	K260577	FilmArray TF Control Panel M527	PMN	2026-05-19
77633	1709044827	K251526	FilmArray GI Control Panel M238	PMN	2025-08-14
77633	1328938847	K241289	SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control	PMN	2024-05-30
77633	1255659962	K230868	SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control	PMN	2023-04-13
77633	1551465218	K203680	BioFire JI Control Panel M420	PMN	2022-07-22
77633	1255471172	K202196	BioFire RP2.1/RP2.1plus Control Panel M441	PMN	2021-06-24
77633	1701395003	K200010	FilmArray BCID2 Control Panel M416	PMN	2020-04-02
77633	1232537316	K190222	FilmArray Pneumonia/Pneumoniaplus Control	PMN	2019-05-03
77633	1980061526	K173171	FilmArray RP2/RP2plus Control Panel	PMN	2017-11-24
77633	1931675403	K163522	FilmArray Warrior Control Panel M290	PMN	2017-03-14
77633	1073466169	K161573	FilmArray RP EZ Control Panel M265	PMN	2016-09-02
77633	1515022880	K083171	INTROL CF PANEL I CONTROL, MODEL: G106	NZB	2008-12-16
77633	1312017792	DEN060007	INTROL CF PANEL I CONTROL	NZB	2006-10-12
77633	1310945260
77633	1521063613

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PMN	11	2026-05-19
NZB	2	2008-12-16

FilmArray GI Control Panel M238
2025-08-14
Maine Molecular Quality Controls, Inc.
SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
2024-05-30
Maine Molecular Quality Controls, Inc.
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
2024-03-26
Maine Molecular Quality Controls, Inc.
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
2023-04-13
Maine Molecular Quality Controls, Inc.
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
2023-02-03
Maine Molecular Quality Controls, Inc.
BioFire JI Control Panel M420
2022-07-22
Maine Molecular Quality Controls, Inc.
BioFire RP2.1/RP2.1plus Control Panel M441
2021-06-24
Maine Molecular Quality Controls, Inc.
FilmArray BCID2 Control Panel M416
2020-04-02
Maine Molecular Quality Controls, Inc.
FilmArray Pneumonia/Pneumoniaplus Control
2019-05-03
Maine Molecular Quality Controls, Inc.
FilmArray RP2/RP2plus Control Panel
2017-11-24
Maine Molecular Quality Controls, Inc.
FilmArray Warrior Control Panel M290
2017-03-14
Maine Molecular Quality Controls, Inc.
FilmArray RP EZ Control Panel M265
2016-09-02
MAINE MOLECULAR QUALITY CONTROLS, INC.
INTROL CF PANEL I CONTROL, MODEL: G106
2008-12-16
MAINE MOLECULAR QUALITY CONTROLS, INC.