SPOTFIRE RSP Positive Control M42638

GUDID 00852720008091

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

Mmqci

Multiple respiratory virus nucleic acid IVD, control
Primary Device ID00852720008091
NIH Device Record Keye315dcea-a85e-414e-b60e-ae9ccfeb6c43
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPOTFIRE RSP Positive Control
Version Model Numberv.00
Catalog NumberM42638
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
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
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
GS100852720008091 [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

Devices Manufactured by Mmqci

00852720008091 - SPOTFIRE RSP Positive Control2023-09-25POS external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in BIOFIRE SPOTFIRE R Panel
00852720008091 - SPOTFIRE RSP Positive Control2023-09-25 POS external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection
00852720008107 - SPOTFIRE RSP Negative Control2023-09-25 NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection
00852720008183 - Xpert BCR-ABL IS p210 Linearity Panel C2072023-09-25 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 M4202022-11-22 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 M4412021-09-24 External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP
00852720008077 - FilmArray BCID2 Control Panel M4162021-02-26 External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the BioFire Bloo
00852720008053 - FilmArray Warrior Control Panel M2902020-12-02 External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray®
00852720008022 - FilmArray Pneumonia/Pneumoniaplus Control2020-05-11 External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pn
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.