To ensure compliance with global regulatory standards and to support robust product traceability, all of MMQCI’s IVD products are assigned a unique Global Trade Item Number (GTIN). The GTIN is a globally recognized identifier governed by GS1 standards and plays a critical role in accurate product identification throughout the entire product lifecycle—from manufacturing and distribution to clinical use and post-market surveillance. In alignment with international regulatory frameworks, the use of GTINs allows our products to be precisely cataloged and seamlessly integrated into global healthcare databases, electronic health records, and inventory management systems.
By leveraging GTINs, MMQCI ensures that each product listing maintains standardized information across all distribution channels. This includes consistent labeling, accurate pricing, real-time stock availability, and interoperability with regulatory and clinical systems worldwide. Ultimately, our commitment to using GTINs reflects our dedication to transparency, quality assurance, and patient safety at every level of the supply chain.
The list below includes GTIN numbers for all MMQCI products that have received FDA regulatory approval.
| P/N | Product Name | Regulatory Status | GTIN |
|---|---|---|---|
| G106ac-1 | INTROL® CF Panel I Control v.02 | CE-IVD & IVD | 00852720008008 |
| G106ac | INTROL® CF Panel I Control v.02 | CE-IVD & IVD | 00852720008015 |
| P/N | Product Name | Regulatory Status | GTIN |
|---|---|---|---|
| M340 | FilmArray® Pneumonia/Pneumoniaplus Control | CE-IVD & IVD | 00852720008022 |
| M416 | FilmArray® BCID2 Control Panel M416 | CE-IVD & IVD | 00852720008077 |
| M420 | BioFire® JI Control Panel M420 | CE-IVD & IVD | 00852720008121 |
| M425 | SPOTFIRE® RSP Pos & Neg Controls | IVD | 00852720008145 |
| M42638 | SPOTFIRE® RSP Positive Control | IVD | 00852720008091 |
| M42738 | SPOTFIRE® RSP Negative Control | IVD | 00852720008107 |
| M441 | BioFire® RP2.1/RP2.1plus Control Panel M441 | CE-IVD & IVD | 00852720008114 |
| P/N | Product Name | Regulatory Status | GTIN |
|---|---|---|---|
| C130 | Xpert BCR-ABL IS Panel C130 | CE-IVD & IVD | 00852720008060 |
| C13112-5 | Xpert BCR-ABL 0%IS | CE-IVD & IVD | 00852720008084 |
| C207 | Xpert BCR-ABL IS p210 Linearity Panel C207 | IVD | 00852720008183 |