Primary Device ID | 00852720008114 |
NIH Device Record Key | d7802ab3-feca-4072-a65b-b769c80ef3f7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BioFire RP2.1/RP2.1plus Control Panel M441 |
Version Model Number | v.00 |
Catalog Number | M441 |
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 |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com | |
Phone | 207-885-1072 |
info@mmqci.com |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00852720008114 [Primary] |
PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-24 |
Device Publish Date | 2021-09-16 |
00852720008091 - SPOTFIRE RSP Positive Control | 2023-09-25 POS external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection |
00852720008107 - SPOTFIRE RSP Negative Control | 2023-09-25 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 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 | 2021-09-24External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2.1/ RP2.1plus assay on the FilmArray 2.0/Torch systems. |
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 |