FilmArray BCID2 Control Panel M416 M416

GUDID 00852720008077

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the BioFire Blood Culture Identification 2 (BCID2) Panel on the FilmArray systems.

Mmqci

Multiple-type bloodstream pathogen nucleic acid IVD, control
Primary Device ID00852720008077
NIH Device Record Key898e7e0c-3292-451d-9b68-d98d831b0a6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilmArray BCID2 Control Panel M416
Version Model Numberv.00
Catalog NumberM416
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852720008077 [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 Date2021-02-26
Device Publish Date2021-02-18

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00852720008442 - Xpert BCR-ABL IS p210 Panel C2062025-06-26 Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for X
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

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