MAINE MOLECULAR QUALITY CONTROLS, INC.

FDA Device Registration & Listing · Saco, ME, US · Registration 3005959679

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005959679
FEI Number
3005959679
Entity Name
MAINE MOLECULAR QUALITY CONTROLS, INC.
City/State/Country
Saco, ME, US
Establishment Address
23 Mill Brook Rd, Saco, ME 04072, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MAINE MOLECULAR QUALITY CONTROLS, INC. (Owner Number: 9081510)
Owner / Operator Contact Address
23 Mill Brook Road, Mill Brook Business Park, Saco, ME 04072, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241289
PMA Number
N/A

All Registered Proprietary Names

SPOTFIRE RSP Positive Control FilmArray Warrior Control Panel M290 FilmArray GI Control Panel M238 Birlinn™ CoV2-Flu-RSV Control Panel M509 SPOTFIRE RSP Negative Control SPOTFIRE RSP Pos & Neg Controls

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays Microbiology Class 2 866.3920 2023-09-15
PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays Microbiology Class 2 866.3920 2020-01-15
PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays Microbiology Class 2 866.3920 2025-11-24
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2025-11-24
PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays Microbiology Class 2 866.3920 2024-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MAINE MOLECULAR QUALITY CONTROLS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005959679. Last updated year: 2026. Please use registration number 3005959679 when referencing this establishment in official correspondence.
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