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MAINE MOLECULAR QUALITY CONTROLS, INC.

USA · Saco

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 12 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

7valid device licences

Class I 7

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States12 registration records, 15 510(k), 0 PMA, 7 excluded

Manufacturer names merged into this page: MAINE MOLECULAR QUALITY CONTROLS, INC.

FDA 510(k) clearances by year

12006

12008

12016

22017

12019

12020

12021

12022

22023

22024

12025

12026

FDA listed device types

Multi-Analyte Controls Unassayed 1Quality Control Material, Genetics, Rna 1Quality Control Material, Genetics, Dna 1Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260577	FilmArray TF Control Panel M527	2026-05-19
US	K251526	FilmArray GI Control Panel M238	2025-08-14
US	K241289	SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control	2024-05-30

MAINE MOLECULAR QUALITY CONTROLS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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