FDA.reportPublic FDA data

BioFire RP2.1/RP2.1plus Control Panel M441

Primary DI
00852720008114
Brand
BioFire RP2.1/RP2.1plus Control Panel M441
Company
Mmqci
Model
v.00
Catalog number
M441
Device description
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2.1/ RP2.1plus assay on the FilmArray 2.0/Torch systems.
Published
2021-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202196000BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc.2021-06-24PMN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852720008114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852720008114008527200081148527200081140852720008114

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple viruses associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
207-885-1072info@mmqci.com

Regulatory Flags#

DUNS number
172874245
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509v.00M5092025-12-04
00852720008275FilmArray GI Control Panel M238v.00M2382025-12-04
00852720008336Birlinn BCR-ABL1 p210 IS Panel C230v.00C2302025-06-20
00852720008367Birlinn BCR-ABL1 p210 IS Control Panel C240v.00C2402025-06-20
00852720008145SPOTFIRE RSP Pos & Neg Controlsv.00M4252025-06-18
00852720008442Xpert BCR-ABL IS p210 Panel C206v.00C2062025-06-18
00852720008091SPOTFIRE RSP Positive Controlv.00M426382023-09-15
00852720008107SPOTFIRE RSP Negative Controlv.00M427382023-09-15
00852720008046FilmArray RP EZ Control Panel M265v.00M2652020-01-22
00852720008039FilmArray RP2/RP2plus Control Panelv.00M3152019-12-31
00852720008183Xpert BCR-ABL IS p210 Linearity Panel C207v.00C2072023-09-15
00852720008121BioFire JI Control Panel M420v.00M4202022-11-14
00852720008077FilmArray BCID2 Control Panel M416v.00M4162021-02-18
00852720008053FilmArray Warrior Control Panel M290v.00M2902020-11-24
00852720008022FilmArray Pneumonia/Pneumoniaplus Controlv.00M3402019-06-17
00852720008084Xpert BCR-ABL 0%ISv.00C13112-52020-01-27
00852720008015INTROL CF Panel I Controlv.02G106ac2019-12-24
00852720008008INTROL CF Panel I Controlv.02G106ac-12019-12-05
00852720008060Xpert BCR-ABL IS Panel C130v.00C1302019-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852720008275FilmArray GI Control Panel M238MmqciPMN2025-12-04
00851458005310BioFire Warrior Panel Control KitBIOFIRE DEFENSE, LLCPMN2025-08-10
00852720008145SPOTFIRE RSP Pos & Neg ControlsMmqciPMN2025-06-18
00850063063012DASH® Negative Control Swabs KitNuclein, LLCPMN2025-01-06
00850063063029DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs KitNuclein, LLCPMN2025-01-06
15420045517059Aptima®Hologic, Inc.PMN2024-12-19
15420045517066Aptima®Hologic, Inc.PMN2024-12-19
30014613340485SavannaDIAGNOSTIC HYBRIDS, INC.PMN2024-04-30
30014613340492SavannaDIAGNOSTIC HYBRIDS, INC.PMN2024-04-30
00852720008091SPOTFIRE RSP Positive ControlMmqciPMN2023-09-15
00852720008107SPOTFIRE RSP Negative ControlMmqciPMN2023-09-15
00851458005273BioFire® Global Fever Special Pathogens PanelBIOFIRE DEFENSE, LLCPMN2023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneBIOFIRE DEFENSE, LLCPMN2023-08-31
00844509002437MDx-Chex for BC-GNSTRECK, INC.PMN2023-08-09
00844509002468MDx-Chex for BC-GPSTRECK, INC.PMN2023-08-09
00852720008121BioFire JI Control Panel M420MmqciPMN2022-11-14
01220000260238NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
01220000260245NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
01220000260252NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
00844509002338MDx-Chex for BCID2STRECK, INC.PMN2022-01-25
00851458005259BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel BIOFIRE DEFENSE, LLCPMN2021-07-16
00852720008077FilmArray BCID2 Control Panel M416MmqciPMN2021-02-18
00852720008053FilmArray Warrior Control Panel M290MmqciPMN2020-11-24
00852720008046FilmArray RP EZ Control Panel M265MmqciPMN2020-01-22
00852720008039FilmArray RP2/RP2plus Control PanelMmqciPMN2019-12-31
70845357041240QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.PMN2019-10-31
70845357041226QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.PMN2019-08-31
70845357041233QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.PMN2019-08-31
15420045512023Aptima®Hologic, Inc.PMN2019-07-02
15420045512030Aptima®Hologic, Inc.PMN2019-07-02