| Primary Device ID | 00852720008084 |
| NIH Device Record Key | 7eb988c2-ef27-499a-bcfe-b4e351dfa9d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xpert BCR-ABL 0%IS |
| Version Model Number | v.00 |
| Catalog Number | C13112-5 |
| 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 |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852720008084 [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 | 2020-02-04 |
| Device Publish Date | 2020-01-27 |
| 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 | 2021-09-24 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 |