FilmArray Pneumonia/Pneumoniaplus Control M340

GUDID 00852720008022

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pneumonia Panel or Pneumonia Panel plus assay on the FilmArray systems.

Mmqci

Multiple respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control Multiple-type respiratory pathogen nucleic acid IVD, control

• Primary Device ID: 00852720008022
• NIH Device Record Key: 41f08d39-2bc1-4ca3-8c73-49ab86c8259d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilmArray Pneumonia/Pneumoniaplus Control
• Version Model Number: v.00
• Catalog Number: M340
• 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: false
• Device Combination Product: false
• Single Use: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852720008022 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-11
• Device Publish Date: 2019-06-17

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• 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