FilmArray RP2/RP2plus Control Panel M315

GUDID 00852720008039

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2 and RP2plus assay on the FilmArray 2.0/Torch systems.

Mmqci

Multiple respiratory virus nucleic acid IVD, control

• Primary Device ID: 00852720008039
• NIH Device Record Key: 8e56bf96-8f0b-4f0e-b154-405c42122bb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilmArray RP2/RP2plus Control Panel
• Version Model Number: v.00
• Catalog Number: M315
• Company DUNS: 172874245
• Company Name: Mmqci
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com
• Phone: 207-885-1072
• Email: info@mmqci.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852720008039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173171

FDA Product Code

• PMN: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-08
• Device Publish Date: 2019-12-31

Devices Manufactured by Mmqci

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• 00852720008183 - Xpert BCR-ABL IS p210 Linearity Panel C207: 2023-09-25 Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for X
• 00852720008121 - BioFire JI Control Panel M420: 2022-11-22 External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures on the BioFire Joint
• 00852720008114 - BioFire RP2.1/RP2.1plus Control Panel M441: 2021-09-24 External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP
• 00852720008077 - FilmArray BCID2 Control Panel M416: 2021-02-26 External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the BioFire Bloo
• 00852720008053 - FilmArray Warrior Control Panel M290: 2020-12-02 External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray®
• 00852720008022 - FilmArray Pneumonia/Pneumoniaplus Control: 2020-05-11 External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pn