SPOTFIRE RSP Negative Control M42738

GUDID 00852720008107

NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in the BIOFIRE SPOTFIRE R Panel

Mmqci

Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control Multiple-genus respiratory virus nucleic acid IVD, control
Primary Device ID00852720008107
NIH Device Record Key1ba55b0f-b774-47e4-9252-ec23e974612e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPOTFIRE RSP Negative Control
Version Model Numberv.00
Catalog NumberM42738
Company DUNS172874245
Company NameMmqci
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852720008107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-25
Device Publish Date2023-09-15

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