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Mmqci

Last updated May 30, 2026

What Mmqci makes

The company manufactures in vitro diagnostic (IVD) controls for nucleic acid testing, including controls for detecting the Philadelphia chromosome/BCR-ABL transcript, respiratory viruses, cystic fibrosis, bloodstream pathogens, *Escherichia coli*, and respiratory pathogens. These controls are designed to validate the performance of molecular assays, ensuring accurate detection and reporting of target genetic sequences in clinical testing.

All listed devices fall under Class II regulatory classification in the United States, with product identifiers recorded in the FDA’s Unique Device Identifier (UDI) database. The manufacturer’s controls are intended for use in laboratory settings to support diagnostic testing and are not cleared or approved as standalone medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: mmqci.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 207-885-1072
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 172874245

Catalogue (18)

Device	Model / Reference	Registries	Class	Status
SPOTFIRE RSP Pos & Neg Controls	v.00	FDA UDI	Class II	Active
Xpert BCR-ABL 0%IS	v.00	FDA UDI	Class II	Active
BioFire RP2.1/RP2.1plus Control Panel M441	v.00	FDA UDI	Class II	Active
Birlinn BCR-ABL1 p210 IS Control Panel C240	v.00	FDA UDI	Class II	Active
SPOTFIRE RSP Negative Control	v.00	FDA UDI	Class II	Active
SPOTFIRE RSP Positive Control	v.00	FDA UDI	Class II	Active
FilmArray RP2/RP2plus Control Panel	v.00	FDA UDI	Class II	Unknown
FilmArray RP EZ Control Panel M265	v.00	FDA UDI	Class II	Unknown
FilmArray Warrior Control Panel M290	v.00	FDA UDI	Class II	Active
Xpert BCR-ABL IS p210 Panel C206	v.00	FDA UDI	Class II	Active
FilmArray Pneumonia/Pneumoniaplus Control	v.00	FDA UDI	Class II	Active
BioFire JI Control Panel M420	v.00	FDA UDI	Class II	Active
Birlinn BCR-ABL1 p210 IS Panel C230	v.00	FDA UDI	Class II	Active
INTROL CF Panel I Control	v.02	FDA UDI	Class II	Active
INTROL CF Panel I Control	v.02	FDA UDI	Class II	Active
Xpert BCR-ABL IS p210 Linearity Panel C207	v.00	FDA UDI	Class II	Active
FilmArray BCID2 Control Panel M416	v.00	FDA UDI	Class II	Active
Xpert BCR-ABL IS Panel C130	v.00	FDA UDI	Class II	Active

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