Primary Device ID | 00852720008183 |
NIH Device Record Key | 4c7afa54-6bac-4363-a805-9a164e9c4441 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Xpert BCR-ABL IS p210 Linearity Panel C207 |
Version Model Number | v.00 |
Catalog Number | C207 |
Company DUNS | 172874245 |
Company Name | Mmqci |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
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 |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00852720008183 [Primary] |
QIG | Quality Control Material, Genetics, Rna |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-25 |
Device Publish Date | 2023-09-15 |
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 | 2023-09-25Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system. |
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 |
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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 |