Maine Molecular Quality Controls, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000035954 FEI 3005959679
- Devices
- 16
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Maine Molecular Quality Controls, Inc. makes
Maine Molecular Quality Controls, Inc. manufactures assayed quality control panels for in vitro nucleic acid testing procedures. Their product portfolio includes control panels for the FilmArray, BioFire RP, BioFire JI, and SPOTFIRE RSP diagnostic systems, which are used to monitor the detection of various viral, bacterial, and parasitic pathogens.
The company is based in the United States, and its products are classified as Class II medical devices. These devices are listed in the FDA 510(k) regulatory registry.
Catalogue
Search and filter all 16 devicesCompany details
- EUDAMED SRN
- US-MF-000035954
- FDA FEI number
- 3005959679
- EUDAMED status
- Active
- EUDAMED registered name
- Maine Molecular Quality Controls, Inc.
- EUDAMED abbreviated name
- MMQCI
- Registered address
- 23, Mill Brook Rd., 04072, Saco, United States
- Website
- www.mmqci.com
- linkedin.com/company/mmqci
- [email protected]
- Phone
- +1-207-885-1072
- PRRC contact
- Gretchen Wight
From the company website
As experts in quality assurance of laboratory medicine, Maine Molecular Quality Controls, Inc. (MMQCI) produces high caliber controls uniquely suited to monitor all phases of molecular testing as required by best practice and regulations. MMQCI controls provide confidence in test results.
Frequently asked questions
How many devices does Maine Molecular Quality Controls, Inc. have in the registry?
The registry currently lists 16 devices for Maine Molecular Quality Controls, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Maine Molecular Quality Controls, Inc.'s devices?
Among its 16 most recently registered devices, Maine Molecular Quality Controls, Inc. has devices listed in EUDAMED (1 device) and FDA 510(k) (15 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Maine Molecular Quality Controls, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Maine Molecular Quality Controls, Inc.'s devices are Class II and IVDR Class B. Each device page shows its own class and authorisation.
What are the newest devices from Maine Molecular Quality Controls, Inc. in the registry?
The most recently registered devices listed for Maine Molecular Quality Controls, Inc. include FilmArray GI Control Panel M238, FilmArray TF Control Panel M527, BioFire RP2.1/RP2.1plus Control Panel M441 and SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738).